Tobacco compositions

ABSTRACT

The invention features tobacco compositions and methods of their use and manufacture. Compositions of the invention may be based on a variety of technologies. Technologies include films, tabs, shaped parts, gels, consumable units, insoluble matrices, and hollow shapes. In addition to tobacco, compositions may also contain flavors, colors, and other additives as described herein. Compositions may also be orally disintegrable. Exemplary compositions and methods of their manufacture are described herein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional application of and claims benefit under35 U.S.C. § 121 to U.S. application Ser. No. 10/982,248, filed Nov. 5,2004, which claims benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication No. 60/518,352, filed Nov. 7, 2003, and U.S. ProvisionalApplication No. 60/603,888, filed Aug. 23, 2004, each of which is herebyincorporated by reference.

FIELD OF THE INVENTION

The invention relates to the field of tobacco products.

SUMMARY OF THE INVENTION

The invention features tobacco compositions and methods of their use andmanufacture. Compositions of the invention may be based on a variety oftechnologies. Technologies include films, tabs, shaped parts, gels,consumable units, insoluble matrices, and hollow shapes. In addition totobacco, compositions may also contain flavors, colors, and otheradditives as described herein. Compositions may also be orallydisintegrable. Exemplary compositions and methods of their manufactureare described herein.

For example, any composition described herein may include a flavor orflavor masking agent. Exemplary flavors include licorice, kudzu,hydrangea, Japanese white bark magnolia leaf, chamomile, fenugreek,clove, menthol, Japanese mint, aniseed, cinnamon, herb, wintergreen,cherry, berry, apple, peach, Drambuie, bourbon, scotch, whiskey,spearmint, peppermint, lavender, cardamon, Apium graveolens, cascarilla,nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil,vanilla, lemon oil, orange oil, cassia, caraway, cognac, jasmine,ylang-ylang, sage, fennel, piment, ginger, anise, coriander, coffee, ora mint oil from any species of the genus Mentha.

Any composition of the invention may also include a sweetener (such assucrose, sucralose, acesulfame potassium, aspartame, saccharine,cyclamates, lactose, sucrose, glucose, fructose, sorbitol, andmannitol); a surfactant; a plasticizer (such as glycerine, propyleneglycol, polyethylene glycol, sorbitol/mannitol, acetylatedmonoglycerides, triacetin, and 1,3 butane diol); a filler (such asstarch, microcrystalline cellulose, wood pulp, soluble fiber, calciumcarbonate, dicalcium phosphate, calcium sulfate, and a clay); alubricant (such as stearic acid and a stearate) or a wax (such aslecithin, glycerol monostearate, and propylene glycol monostearate); apreservative (such as methyl paraben and potassium sorbate); and/or astabilizer (such as ascorbic acid, monosterol citrate, BHT, and BHA).

Any composition described herein may further include a coating, e.g.,matte or glossy. The coating preferably includes a color, flavor,sweetener, or flavor masking agent. The coating may also include adifferent flavor, color, or rate of disintegration from the format inthe composition. The coating may also include tobacco.

Any composition described herein may further include a printed pattern,e.g., in a logo. A printed pattern may include a color, tobacco, aflavor, sweetener, or flavor masking agent. The surface of anycomposition described herein may also include a pattern in relief.

Tobacco included in any composition may be a powder, granules, shreds,or perceived to be soluble in the mouth.

Any composition described herein may further include flakes, e.g.,containing tobacco or a plurality of flavors or colors.

Any composition of the invention may be formed in a shape suitable forapplication in the mouth. A composition of the invention may furtherprovide tobacco satisfaction, e.g., over a period of 10 s to 30 minutes.

The invention also features a method for obtaining tobacco satisfactionby placing at least a portion of any composition as described herein inthe mouth.

The invention also features methods for making compositions as describedherein. Any of these methods may further include adding a coating to thecomposition, e.g., by spraying, brushing, roll coating, doctor barcasting, slot coating, extrusion coating, or hot melt deposition. Any ofthe methods may also include printing a pattern on the composition,e.g., by offset, flexographic, gravure, ink jet, laser, or screenprinting. In addition, the methods of making compositions may includeadding a flavor, color, flavor masking agent, or any other ingredientdescribed herein to the format or composition.

By “format” is meant an ingredient or compilation of ingredients, asprovided herein, in a composition, for example, a carrier or agent.

By “tobacco” is meant any part, e.g., leaves, flowers, roots, and stems,of any member of the genus Nicotiana. Exemplary species of tobaccoinclude N. rustica and N. tabacum (e.g., LA B21, LN KY171, TI 1406,Basma, Galpao, Perique, Beinhart 1000-1, and Petico). Other speciesinclude N. acaulis, N. acuminata, N acuminata var. multiflora, N.africana, N. alata, N. amplexicaulis, N. arentsii, N. attenuata, N.benavidesii, N. benthamiana, N. bigelovii, N. bonariensis, N. cavicola,N. clevelandii, N. cordifolia, N. corymbosa, N. debneyi, N. excelsior,N. forgetiana, N. fragrans, N. glauca, N. glutinosa, N. goodspeedii, N.gossei, N. hybrid, N. ingulba, N. kawakamii, N. knightiana, N.langsdorffii, N. linearis, N. longiflora, N. maritima, N. megalosiphon,N. miersii, N. noctiflora, N. nudicaulis, N. obtusifolia, N.occidentalis, N. occidentalis subsp. hesperis, N. otophora, N.paniculata, N. pauciflora, N. petunioides, N. plumbaginifolia, N.quadrivalvis, N. raimondii, N. repanda, N. rosulata, N. rosulata subsp.ingulba, N. rotundifolia, N. setchellii, N. simulans, N. solanifolia, N.spegazzinii, N. stocktonii, N. suaveolens, N. sylvestris, N.thyrsiflora, N. tomentosa, N. tomentosiformis, N. trigonophylla, N.umbratica, N. undulata, N. velutina, N. wigandioides, and N. x sanderae.The tobacco may be whole, shredded, cut, cured, aged, fermented, orotherwise processed, e.g., granulated or encapsulated. Tobacco may alsobe in the form of finished products, including but not limited to anynon-combustible tobacco that is orally consumed, e.g., smokelesstobacco. Such smokeless tobacco includes snuff (moist or dry), chewingtobacco, loose tobacco, pouched tobacco, and the like, or any formcontained herein. The term also includes an extract of tobacco includingtwo or more tobacco organoleptic components.

By “tobacco satisfaction,” in this case, is meant the experienceassociated with tobacco organoleptic components and added flavorcomponents that are released in the mouth when using a smokelesstobacco. An adult consumer who chooses to use a smokeless tobaccoproduct purchases a smokeless tobacco product typically according totheir individual preference, such a preference includes, withoutlimitation, flavor, cut of tobacco, form, ease of use, and packaging.

By “organoleptic” is meant relating or contributing to the integratedsensory perception by the consumer that includes, for example, anycombination of aroma, fragrance, flavor, taste, odor, mouth feel, or thelike.

By “non-combustible” is meant does not combust during ordinary usage.

Compositions described herein are advantageous from the perspective ofsize, ease of use, and controlled rate of disintegration.

All percentages are by weight unless otherwise noted.

Other features and advantages will be apparent from the followingdescription and the claims.

DETAILED DESCRIPTION OF THE INVENTION

The invention features tobacco compositions that are typically fortobacco satisfaction.

A. Tobacco

Tobacco useful in compositions described herein includes any raw orprocessed form, e.g., a powder, granule, or shred. Preferably, thetobacco is sized or made to disintegrate in the mouth (e.g., dissolve),to give the perception of dissolvability (e.g., the tobacco does notproduce a tactile experience in the mouth), or to be easily swallowed.Alternatively, the tobacco may be sized or made to provide a tactileexperience in the mouth. Exemplary average sizes are in the range of 1to 1000 μm, e.g., about 800, 500, 250, 100, 80, 75, 50, 25, 20, 15, 10,8, 6, 5, 3, 2, or 1 μm or less, preferably 80 μm or less. The tobaccomay also be in the form of a slurry or a flowable gel. A flowable gel isa mixture of a format dissolved in water and mixed with tobacco and thenmixed with a miscible solvent that prevents the complete dissolution ofthe format. Such a mixture causes the format to swell forming a viscouspaste that is pseudoplastic and is easily dispensed from a container(e.g., a tube) with slight pressure. An exemplary tobacco is smokelesstobacco. Additional tobaccos are described in U.S. Pat. No. 6,953,040issued Oct. 11, 2005; U.S. Pat. No. 7,032,601 issued Apr. 25, 2006; andU.S. Pat. No. 7,798,153 issued Sep. 21, 2010, the disclosures of whichare hereby incorporated by reference. The tobacco employed in thecomposition may also be prepared according to the methods of U.S. Pat.No. 7,798,151 issued Sep. 21, 2010; the disclosure of which is herebyincorporated by reference. Other suitable tobacco is known in the art.

Tobacco may be distributed randomly or evenly throughout a compositionor concentrated in various regions thereof, e.g., in the center or onthe surface.

Depending on the desired characteristics and the end use of thecomposition, the typical final tobacco concentration ranges from 1percent to 99 percent by weight of the final composition, for example,at most 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85,or 90%. In preferred embodiments, the composition includes around 25%tobacco.

B. Compositions

In general, compositions of the invention are intended for oral use orconsumption. A composition containing tobacco may be manufactured usingany suitable orally compatible format. The tobacco may be mixed directlywith the format or otherwise supported by the format. For example, acomposition may contain tobacco, e.g., as dried particles, shreds,granules, a powder, or a slurry, deposited on, mixed in, surrounded by,or otherwise combined with a format. Tobacco in compositions may or maynot be, or be perceived to be, soluble. In one embodiment, thecompositions are spitless tobacco compositions. Compositions may alsoinclude a mixture of forms or types of tobacco. Compositions may befoamed or dense. Foamed compositions may be rigid or flexible and may bebased on water soluble, water insoluble, or thermoplastic formats.Exemplary compositions are described herein. In one embodiment, acomposition of the invention is non-combustible.

Formats suitable for use in the compositions described herein includeorally compatible polymers, such as cellulosics (e.g., carboxymethylcellulose (CMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose(HEC), hydroxypropyl methyl cellulose (HPMC), and methyl cellulose(MC)), natural polymers (e.g., starches and modified starches, konjac,collagen, inulin, soy protein, whey protein, casein, and wheat gluten),seaweed-derived polymers (e.g., carrageenan (kappa, iota, and lambda),alginates, and propylene glycol alginate), microbial-derived polymers(e.g., xanthan, dextran, pullulan, curdlan, and gellan), extracts (e.g.,locust bean gum, guar gum, tara gum, gum tragacanth, pectin (lo methoxyand amidated), agar, zein, karaya, gelatin, psyllium seed, chitin, andchitosan), exudates (e.g., gum acacia (arabic) and shellac), syntheticpolymers (e.g., polyvinyl pyrrolidone, polyethylene oxide, and polyvinylalcohol). Other useful formats are known in the art, for example, seeKrochta et al. Food Technology, 1997, 51:61-74, Glicksman FoodHydrocolloids CRC 1982, Krochta Edible Coatings and Films to ImproveFood Quality Technomic 1994, Industrial Gums Academic 1993, NussinovitchWater-Soluble Polymer Applications in Foods Blackwell Science 2003.Depending on the desired characteristics, a composition may also includefillers (e.g., starch, microcrystalline cellulose, wood pulp (e.g.,Solkafloc from International Fibers, Inc.), soluble fiber (e.g.,Fibersol from Matsushita), calcium carbonate, dicalcium phosphate,calcium sulfate, and clays), lubricants (e.g., lecithin, stearic acid,stearates (e.g., Mg or K), and waxes (e.g., glycerol monostearate,propylene glycol monostearate, and acetylated monoglycerides)),plasticizers (e.g., glycerine, propylene glycol, polyethylene glycol,sorbitol, mannitol, triacetin, and 1,3 butane diol), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), or other compounds(e.g., vegetable oils, surfactants, and preservatives). Some compoundsfunction as both plasticizers and lubricants.

Compositions of the invention may include flavor extracts (e.g.,licorice, kudzu, hydrangea, Japanese white bark magnolia leaf,chamomile, fenugreek, clove, menthol, Japanese mint, aniseed, cinnamon,herb, wintergreen, cherry, berry, peach, apple, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cardamon, Apiumgraveolens, cascarilla, nutmeg, sandalwood, bergamot, geranium, honeyessence, rose oil, vanilla, lemon oil, orange oil, cassia, caraway,cognac, jasmine, ylang-ylang, sage, fennel, piment, ginger, anise,coriander, coffee, or a mint oil from any species of the genus Mentha),flavor masking agents, bitterness receptor site blockers, receptor siteenhancers, sweeteners (e.g., sucralose, acesulfame potassium (Ace-K),aspartame, saccharine, cyclamates, lactose, sucrose, glucose, fructose,sorbitol, and mannitol), and other desirable additives such aschlorophyll, minerals, botanicals, or breath freshening agents.

Flavors may also be provided by plant matter, e.g., mint leaves, whichare typically 10% flavor oils and 90% insoluble fiber. Exemplary plantsfurther include licorice, kudzu, hydrangea, Japanese white barkmagnolia, chamomile, fenugreek, clove, Japanese mint, cinnamon, herb,cherry, berry, peach, apple, lavender, cardamon, Apium graveolens,cascarilla, nutmeg, sandalwood, bergamot, geranium, rose, vanilla,lemon, orange, cassia, caraway, jasmine, ylang-ylang, sage, fennel,piment, ginger, anise, coriander, coffee, or any species of the genusMentha.

Flavor may be provided to a composition as described herein by flavorextracts, plant matter, or a combination thereof. In addition to naturalflavor extracts, flavor may also be provided by imitation, synthetic, orartificial flavor ingredients and blends containing such ingredients.Flavors may be added as a powder, an oil, or in encapsulated form.

In certain embodiments, the composition disintegrates in the mouth.Disintegration rates of compositions may vary from 60 minutes to lessthan 1 minute. Fast release compositions typically disintegrate in under2 minutes and most preferably, in 1 minute or less, e.g., less than 60s, 50 s, 45 s, 40 s, 35 s, 30 s, 25 s, 20 s, 15 s, 10 s, 5 s, 4 s, 3 s,2 s, or 1 s. The disintegration may occur by any mechanism, for example,dissolution, melting, mechanical disruption (e.g., from chewing),enzymatic or other chemical degradation, or disruption of theinteraction between the format and tobacco. The format or tobacco itselfmay similarly disintegrate. The amount of time required for acomposition to disintegrate may be controlled by varying the thicknessof the composition and is dependent upon the type of format, otheradditives, and the pattern of usage. When placed in the mouth, thecomposition may temporarily adhere to a part of the oral mucosa. Inaddition, the length of time of the tobacco satisfaction may vary. Thislength of time may be affected by, e.g., by the rate of disintegrationof a composition, the rate of extraction of organoleptic components froma composition, and the residence time of the composition in the mouth.The tobacco satisfaction may be provided over a period of at least 10 s,30 s, 45 s, 1 min 2 min 3 min 5 min 10, min 15 min, 30 min, or 1 h,preferably from 10 s to 10 minutes and more preferably from 30 s to 5minutes.

In other embodiments, the compositions do not disintegrate over theresidence period in the mouth. In such compositions, introduction oftobacco organoleptic components into the mouth may occur by dissolution,leaching, extraction, or mechanical disruption caused by chewing.

Individual compositions may be sized to fit entirely in the mouth, orthey may be sized to fit only partially in the mouth. Preferred crosssections of the compositions include, but are not limited to, square,circular, rectangular, elliptical, oval, and the like. Preferreddimensions may vary depending upon the serving size and ingredients.Typically, the largest dimension of a single serving is 5 cm or smaller.Alternatively, tobacco products may be made in a larger form, from whichindividual servings may be cut or otherwise separated, e.g., by chewing,biting, or oral disintegration. For example, a strip, or other longpiece, may be placed in a container, and the consumer may remove adesired serving size. A larger composition (or orally sized pieceattached to a handle) may also be partially inserted in the mouth,similar to a toothpick or cigarette, and the consumer may suck or chewon it. In one embodiment, the larger piece is orally disintegrable andmay be completely consumed over a period of time.

C. Technologies

Films. Compositions of the invention may be formed as films that may beorally disintegrable. Such films may contain a single layer or multiplelayers. A single layer film will contain tobacco, a format, and otheringredients, e.g., in a homogeneous mixture. Multilayer films mayinclude several tobacco containing layers, e.g., with the same ordifferent kind or size of tobacco, e.g., tobacco perceived to besoluble. Multiple layers may be laminated together. In addition,multilayer films may contain tobacco in one or more layers and otherlayers that contain additional ingredients, as described herein. Forexample, individual layers may be added for flavor, sweetness, color,rate of disintegration, or stability (e.g., during handling or duringconsumption). Tobacco may also be placed between two or more layers in asandwich arrangement. One or more of the layers in the sandwich may alsoinclude tobacco. In films having multiple layers, the layers maydisintegrate at the same or different rates, or a layer may notdisintegrate orally. When rates of disintegration differ, thecomposition may provide tobacco at differing times based on the layersdisintegrating. Single layer films or individual layers in multilayerfilms may also be foamed or aerated to provide desirable physicalproperties or desirable dissolution or disintegration rates.

Films may be sized to fit in the mouth as individual servings.Alternatively, larger films may be fabricated from which individualservings may be separated. For example, a film may be wrapped, orotherwise shaped, to form a hollow tube or straw, which in turn may befilled with additional material. In addition, a film, e.g., containing ahigh percentage of tobacco in the range of 1% to 99% based on dryweight, may be fabricated and then used in preparation of flakes or apowder for addition to other compositions, as described herein. Thepreferred thickness of a film is typically less than 1 mm, e.g., lessthan 500, 200, 100, 50, 40, 30, 20, 10, 5, 4, 3, 2, or 1 μm; preferably5 to 125 μm.

Various methods known in the art can be used to manufacture films. Thetechnique employed may depend on the format employed in the film.Exemplary methods include solution casting or extrusion, melt extrusion,drum drying, and calendaring. Once formed, a film may be modified, e.g.,by printing or otherwise coating or decorating the surface of the film.Flavors, colors, or tobacco may be added to the surface of a film by aprinting, coating, or decorative process. All printing processes knownin the art, e.g., offset, flexographic, gravure, ink jet, laser, screenprinting, and other typical methods, may be used. Coatings or decorativepatterns may be applied to the surface of the film using processes knownin the art, e.g., spraying, brushing, roll coating, doctor bar casting,slot coating, extrusion coating, hot melt deposition, depositingparticles or flakes, and other typical methods. The film to be printed,coated, or decorated may or may not contain tobacco. One function of theprinting, coating, or decorative pattern is to provide additionalamounts of color, flavor, or tobacco to the film. Another function is toimprove the dimensional stability and appearance of the film. Once theprinted, coated, or decorated film has been prepared, an additionallayer of film may be applied to cover, protect and seal the printed,coated, or decorated surface.

Film Examples

The following table shows exemplary ingredients for fabricating films ofthe invention.

TABLE A1 Exemplary (%) Preferred (%) Example A (%) Water soluble polymer10-70  20-45 30 Tobacco 1-90 20-40 25 Flavor 1-40  5-15 10 Sweetener0.2-6   2-5 3 Fiber (Soluble or 2-40  5-20 9 insoluble) Plasticizer 1-40 5-15 10 Surfactants 0.05-5    0.1-1   0.5 Starch/Maltodextrin 1-4010-20 10.5 Lubricant 0.5-10   1-3 2

Example B Tobacco Film

A mixture of 50 grams of K-3 (60%), K-100 (35%) and K4M (5%) grades ofhydroxypropylmethyl cellulose (HPMC) from Dow Chemical are added to abeaker containing 450 grams of well agitated, deionized water which hasbeen heated to 180° F. While mixing, 40 grams of finely ground tobaccois added to the HPMC solution along with 15 grams of microcrystallinecellulose (FMC), 17 grams of starch (B-700 from Grain Processing Corp.),16 grams of glycerine, 0.8 grams of polysorbate 80 (Unichema), and 4grams of propylene glycol monostearate (PGMS from Danisco). Ten grams ofcinnamon flavor and 2 grams of sucralose (artificial sweetener) areadded to the solution when the temperature has dropped below 100° F. Twograms of sodium carbonate is added to adjust pH to approximately 7.5.Once all ingredients have been added and have been uniformly dispersed,the mixture is place in a water bath and, with continued mixing for 30minutes, is reduced in temperature to 65° F. Additional water is addedas required to obtain a Brookfield viscosity of 5,000 centipoise at atemperature of 65° F.

A portion of this tobacco containing solution described above is thenspread on a glass plate using a draw down blade with a fixed gap of 15mils (0.015 inches). The glass plate is placed in an air circulatinglaboratory oven preset at a temperature of 170° F. After 30 minutes, theglass plate is removed from the oven, cooled to room temperature, andthe dry film with a thickness of 2.5 mils (0.0025 inches) is removedfrom the glass plate. The film may then be cut into smaller piecessuitable for placing in the mouth. A 1.0 inch by 1.25 inch section ofthe film will typically disintegrate in the mouth in less than oneminute, thereby releasing the flavor, sweetener, and tobacco. Thetobacco content of this film on a dry weight basis is 25%.

Example C Opaque, Flavored Film

Using the same procedure as Example B, a solution is prepared withoutthe addition of tobacco. While the solution is still hot, 32 grams of atitanium dioxide dispersion (50% titanium dioxide in water) supplied bySensient Colors and 0.01 grams of FD&C Red No. 40 lake (Sensient Colors)are added with agitation. The solution is cooled to 65° F. and is spreadon a glass plate, dried, and removed from the glass plate as describedin Example B. An opaque, light red film of good strength and a dry filmthickness of 1.5 mils (0.015 inches) is produced.

Example D Two Layer Film

A portion of the solution from Example B is spread on a glass plateusing a draw down blade with a fixed gap of 15 mils (0.015 inches). Theglass plate is placed in a laboratory oven and the film is dried as inExample B. The glass plate is removed from the oven and cooled to roomtemperature, but the film is not removed from the glass plate.

A portion of the solution from Example C is spread over the dry film ofExample B using a draw down blade with a fixed gap of 5 mils (0.005inches). The glass plate is placed in the laboratory oven at 170° F. for10 minutes. The dry film with a thickness of 3 mils (0.003 inches) isremoved from the glass plate. The film is distinctly two sided with alayer of brown, tobacco containing film on one side and a red, flavoredfilm on the opposite side. A 1.0 inch by 1.25 inch section of the filmwill typically disintegrate in the mouth in less than one minute.

Example E Three Layer Film

A portion of the solution from Example C is spread on a glass plateusing a draw down blade with a fixed gap of 5 mils and is dried in thelaboratory oven as before. A portion of the solution from Example B isspread over the dried film of Example C using a draw down blade with afixed gap of 15 mils and is dried in the laboratory oven as before. Aportion of the solution from Example C is spread on a glass plate usinga draw down blade with a fixed gap of 5 mils and is dried in thelaboratory oven as before. The resulting film is 3 mils (0.003 inches)in thickness and is comprised of three layers with a layer of opaque,red, flavored film on either side and a center layer of tobaccocontaining film. A 1.0 inch by 1.25 inch section of the film willtypically disintegrate in the mouth in less than one minute.

Example F Foamed Film

To a 100 gram portion of tobacco containing solution from Example B isadded with vigorous mixing, 0.5 grams of sodium lauryl sulfate (asurface active agent). This solution is then mixed on a high shear mixersuch as a Silverson Laboratory Homogenizer, Model L4RT-W, to create auniform bubble structure. This highly aerated solution is then spread ona glass plate using a draw down blade with a fixed gap of 4 mils (0.040inches) and is dried in a laboratory oven. The dry, foamed film has athickness of 4 mils (0.004 inches) when it is removed from the glassplate. The weight of a section of this foamed film of 1.0 inch by 1.25inch by 4 mils (0.004 inches) in thickness is 35% lower than anidentical section of unfoamed film as prepared in Example B. Thedissolution rate of the foamed film in the mouth is typically fasterwhen compared to the identical unfoamed film as prepared in Example B.

Example G Flakes

A solution is prepared in a beaker by adding 40 grams of spray dried GumArabic (TIC Gums, Inc.) and 0.4 grams of propylene glycol monostearate(PGMS) to 60 grams deionized water while mixing vigorously for 30minutes. To 10 grams of this solution, 0.01 grams of FD&C Red No. 40lake is added with high agitation to ensure uniform dispersion of thecolor. The solution is covered and set aside for 24 hours to permit allentrapped air to dissipate. A portion of this solution is then spread ona glass plate using a draw down blade with a fixed gap of 5 mils (0.005inches). The glass plate is placed in a laboratory oven preset at 170°F. for 20 minutes until the film is thoroughly dried. When the film isremoved from the glass plate, it breaks into many small pieces of highgloss, colorful, red flakes. This process is repeated with other FD&Clakes to produce flakes of many different colors. Flavors and artificialsweeteners can also be added to the flakes.

Example H Tobacco Flakes

To 10 grams of the solution prepared in Example G is added 4 grams offinely ground tobacco powder. Films are prepared on glass plates and aredried, cooled, and removed in the same manner as in Example G. Theresulting flakes are composed of 50% tobacco and 50% Gum Arabic and area deep brown color. Flavors, if desired, can be added to the flakes.Materials such as sodium carbonate can also be added to the flakes toadjust pH.

Example I Tobacco Film with Flakes

A film is prepared as in Example B. While the film is still wet on theglass plate, a measured quantity of flakes are prepared and are spreaduniformly over the wet film. The glass plate is then dried in alaboratory oven; the film is cooled to room temperature and then removedfrom the glass plate. Typically, the dried film of Example B has a dryweight of 1 gram (containing 25% or 0.25 grams of tobacco). If this filmis divided into 20 equal sections of film (1.0 inch by 1.25 inches by 2mils), each section will weigh 50 milligrams (containing 25% or 12.5milligrams of tobacco). If one gram of tobacco flakes (which are 50% byweight of tobacco) are spread uniformly over the film, the full piece offilm will have a dry weight of 2 grams (containing a total of 0.75 gramsof tobacco). When divided into 20 equal sections, each section willweigh 100 milligrams and will contain 37.5 milligrams of tobacco. Thesection of film cut into a 1.0 inch by 1.25 inch size will typicallydisintegrate in the mouth in less than one minute.

Example J Tobacco Film with Decorative Flakes

The procedure outlined in Example I can be repeated using decorativeflakes (e.g., colored flakes which do not contain any tobacco) or withblends of colored flakes and tobacco containing flakes. The resultingfilms have a colorful appearance.

Example K Flavored Tobacco Film

TABLE K1 HPMC 36.56% Starch 12.18% Tobacco 24.37% Na₂CO₃ 1.46%Plasticizer 13.15% Flavors 6.82% Sweetener 0.49% Surfactant 0.97% Water4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 30.98 g HM100PA2208 (WolffCellulosics) 15.51 g HM4000PA2910 (Wolff Cellulosics)  2.60 g B700(Grain Processing Corporation) 16.36 g Tobacco Powder (average particlesize < 80 μm) 32.72 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 1.96 g Propylene Glycol Monostearate 0.65 g Sodium LaurylSulfate 0.65 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 5.89 g Propylene Glycol 5.22 g Polyethylene Glycol 4006.54 g Cinnamon Flavor 6.54 g Tobacco Flavor Modifier (Hagelin) 2.62 gSucralose Solution 25% (Tate & Lyle) 2.62 g

A total of 619.14 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point MIX1 was added. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10,000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platethat had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 15 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 30 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet and cut into appropriatelysized units. A 1.0 inch by 1.25 inch unit of film disintegrated in themouth in less than 30 seconds.

Relatively slower disintegrating films (e.g., films disintegrating inthe mouth in greater than 30 seconds) were produced from the samesolutions by casting the solution across the glass plate with adraw-down knife with a fixed gap of 30 mils. The films were dried in thesame manner as above for 40 minutes. The films produced typicallydisintegrated in the mouth in less than 1 minute.

Super-fast disintegrating films (e.g., films disintegrating in the mouthin less than 15 seconds) were produced from the same solutions byfoaming the solution prior to casting on the glass plate. Foaming wasaccomplished by subjecting 100 g of each solution to high shear mixing(with an Arrow Model 1750 high shear mixer) for approximately 3 minutes,after which the foamed solution was immediately cast on the glass platewith a draw-down knife with a fixed gap of 30 mils. The films producedtypically disintegrated in the mouth in less than 15 seconds.

Example L Flavored Tobacco Film

TABLE L1 HPMC 36.56% Starch 12.18% Tobacco 24.37% Na₂CO₃ 1.46%Plasticizer 10.71% Flavors 9.26% Sweetener 0.49% Surfactant 0.97% Water4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 30.98 g HM100PA2208 (WolffCellulosics) 15.51 g HM4000PA2910 (Wolff Cellulosics)  2.60 g B700(Grain Processing Corporation) 16.36 g Tobacco Powder (avg. particlesize <80 μm) 32.72 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 1.96 g Propylene Glycol Monostearate 0.65 g Sodium LaurylSulfate 0.65 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 4.58 g Propylene Glycol 5.22 g Polyethylene Glycol 4004.58 g Mint Flavor 9.81 g Tobacco Flavor Modifier (Hagelin) 2.62 gSucralose Solution 25% (Tate & Lyle) 2.62 g

A total of 619.14 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point MIX1 was added. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platethat had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 15 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 30 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet and cut into appropriatelysized units. A 1.0 inch by 1.25 inch unit of film typicallydisintegrated in the mouth in 15-30 seconds.

Alternatively, the film includes wintergreen, spearmint, or appleflavor.

Relatively slower disintegrating films (e.g., films disintegrating inthe mouth in greater than 30 seconds) and super-fast disintegratingfilms (e.g., films disintegrating in the mouth in less than 15 seconds)were produced from the same solutions as described in Example K.

Example M Peach Flavored Tobacco Film

TABLE M1 HPMC 29.12% Starch 9.71% Tobacco 19.41% Na₂CO₃ 1.16%Plasticizer 2.33% Peach Puree 29.66% Flavors 3.43% Sweetener 0.39%Surfactant 0.77% Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 30.98 g HM100PA2208 (WolffCellulosics) 15.51 g HM4000PA2910 (Wolff Cellulosics)  2.60 g B700(Grain Processing Corporation) 16.36 g Tobacco Powder (average particlesize <80 μm) 32.72 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 1.96 g Propylene Glycol Monostearate 0.65 g Sodium LaurylSulfate 0.65 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 1.31 g Propylene Glycol 1.31 g Polyethylene Glycol 4001.31 g Peach Puree 100.0 g  Peach Flavor 3.27 g Tobacco Flavor Modifier(Hagelin) 2.62 g Sucralose Solution 25% (Tate & Lyle) 2.62 g

A total of 619.14 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point MIX1 was added. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 15 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 30 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet, and cut intoappropriately sized units. A 1.0 inch by 1.25 inch unit of filmtypically disintegrated in the mouth in 15-30 seconds.

Relatively slower disintegrating films (e.g., films disintegrating inthe mouth in greater than 30 seconds) and super-fast disintegratingfilms (e.g., films disintegrating in the mouth in less than 15 seconds)were produced from the same solutions as described in Example K.

Example N Flavored Tobacco Film for Sticks/Wraps/Pouches/Vacuum Forming

TABLE N1 HPMC 41.31% Starch 13.76% Tobacco 9.75% Na₂CO₃ 1.46%Plasticizer 18.99% Flavors 9.27% Sweetener 0.49% Surfactant 0.98% Water4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 38.48 g HM100PA2208 (WolffCellulosics) 19.27 g HM4000PA2910 (Wolff Cellulosics)  3.24 g B700(Grain Processing Corporation) 20.32 g Tobacco Powder (avg. particlesize <80 μm) 14.39 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 2.16 g Propylene Glycol Monostearate 0.72 g Sodium LaurylSulfate 0.72 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 7.19 g Propylene Glycol 7.19 g Polyethylene Glycol 4007.19 g Triacetin 6.47 g Cinnamon Flavor 10.80 g  Tobacco Flavor Modifier(Hagelin) 2.88 g Sucralose Solution 25% (Tate & Lyle) 2.88 g

A total of 606.10 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point MIX1 was added. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet, and was stored in aplastic bag for future use.

Alternatively flavored tobacco films, e.g., apple flavored, were alsoproduced following the preceding formulation and procedure.

Example O Flavored/Colored Film for Sticks/Wraps/Pouches

TABLE O1 HPMC 41.31% Starch 13.76% Fibersol-2 9.75% Na₂CO₃ 1.46%Plasticizer 18.99% Flavors 9.26% Sweetener 0.49% Surfactant 0.79% Color0.20% Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 38.48 g HM100PA2208 (WolffCellulosics) 19.27 g HM4000PA2910 (Wolff Cellulosics)  3.24 g B700(Grain Processing Corporation) 20.32 g Fibersol-2 (Matsutani) 14.39 gFD&C Red 40 Alum Lake 35-42% (Sensient Colors)  0.29 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 2.16 g Propylene Glycol Monostearate 0.58 g Sodium LaurylSulfate 0.58 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 7.19 g Propylene Glycol 7.19 g Polyethylene Glycol 4007.19 g Triacetin 6.47 g Cinnamon Flavor 10.79 g  Tobacco Flavor Modifier(Hagelin) 2.88 g Sucralose Solution 25% (Tate & Lyle) 2.88 g

A total of 606.10 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches) for2 minutes at 7500 RPM, after which an ice bath was placed around thehomogenizer vessel. Homogenization continued under vacuum (20-25 inches)for 8 minutes at 10000 RPM. After homogenization was complete, a portionof the solution was transferred to a 500-mL Nalgene bottle for storage.

A portion of the resultant gel solution was poured onto a glass platethat had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. Additional films were cast at 40 mils, anddried for 1 hour. The resultant films dried to approximately 4%moisture, were removed from the Mylar sheet, and were stored in aplastic bag for future use.

Alternatively flavors include mint flavor, wintergreen flavor, orspearmint flavor. Alternative colors include FD&C Blue Alum Lake 35-42%,FD&C Emerald Green Lake Blend, and FD&C Blue Alum Lake+FD&C EmeraldGreen Lake Blend.

Example P Peach Flavored Film for Sticks/Wraps/Pouches

TABLE P1 HPMC 31.73% Starch 10.57% Tobacco  7.49% Na₂CO₃  1.12%Plasticizer 14.59% Peach Puree 26.01% Flavors  3.37% Sweetener  0.37%Surfactant  0.75% Water  4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 38.48 g HM100PA2208 (WolffCellulosics) 19.27 g HM4000PA2910 (Wolff Cellulosics)  3.24 g B700(Grain Processing Corporation) 20.32 g Tobacco Powder (average particlesize < 80 μm) 14.39 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 2.16 g Propylene Glycol Monostearate 0.72 g Sodium LaurylSulfate 0.72 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 7.19 g Propylene Glycol 7.19 g Polyethylene Glycol 4007.19 g Triacetin 6.47 g Peach Puree 100.0 g  Peach Flavor 3.60 g TobaccoFlavor Modifier (Hagelin) 2.88 g Sucralose Solution 25% (Tate & Lyle)2.88 g

A total of 606.10 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platethat had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet, and was stored in aplastic bag for future use.

Example Q Flavored/White Opaque Film for Coating

TABLE Q1 HPMC 45.46% Starch 15.15% Fibersol-2 10.73% Na₂CO₃ 1.07%Plasticizer 10.73% TiO₂ 10.45% Flavors 1.07% Sweetener 0.27% Surfactant1.07% Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 38.48 g HM100PA2208 (WolffCellulosics) 19.27 g HM4000PA2910 (Wolff Cellulosics)  3.24 g B700(Grain Processing Corporation) 20.32 g Fibersol-2 (Matsutani) 14.39 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 1.44 g Propylene Glycol Monostearate 0.72 g Sodium LaurylSulfate 0.72 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 3.60 g Propylene Glycol 3.60 g Polyethylene Glycol 4003.60 g Triacetin 3.60 g TiO₂ suspension 50% (Sensient Colors) 28.04 g Tobacco Flavor Modifier (Hagelin) 1.44 g Sucralose Solution 25% (Tate &Lyle) 1.44 g

A total of 606.10 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 1 minute. The resultant solution wastransferred to a Silverson SS1 vessel, which had been adapted for mixingunder vacuum. The vessel was attached to a Silverson L4RTU homogenizermotor unit. The solution was homogenized under vacuum (20-25 inches ofHg) for 2 minutes at 7500 RPM, after which an ice bath was placed aroundthe homogenizer vessel. Homogenization continued under vacuum (20-25inches of Hg) for 8 minutes at 10000 RPM. After homogenization wascomplete, a portion of the solution was transferred to a 500-mL Nalgenebottle for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film, dried to approximately4% moisture, was removed from the Mylar sheet, and was stored in aplastic bag for future use.

Example R Extruded Tobacco Films

TABLE R1 Tobacco 25.63%  Klucel LF 61.53%  Na₂CO₃ 3.32% Plasticizer6.68% Sweetener 0.83% Water 2.00%

The following ingredients were granulated in a manner similar togranulations utilized for tab production, as described herein, yieldinga tobacco granulation with an approximate moisture of 4.50%:

Klucel LF (Hercules/Aqualon) 3448.0 g Na₂CO₃  181.0 g Sucralose (Tate &Lyle)  45.0 g Propylene Glycol  363.0 g Tobacco Powder (average particlesize <80 μm) 1451.0 g Water 2344.0 g

The tobacco granulation was introduced to the feed section of aLeistritz Micro-18 Twin Screw Extruder 40:1 L/D, which had beenconfigured for co-rotating extrusion with a medium-shear screw design.Feed rates for the extrusion varied between 1-3 pounds per hour. Barrelzone temperatures varied between 75-240° F. Venting of volatiles fromthe extrusion melt was accomplished by incorporating a venting orificeprior to the discharge die of the extruder.

Tobacco film, with a width of approximately 3 inches and a thicknessvarying from 2-3 mils, was produced by incorporating a strip die at thedischarge end of the extruder. Upon discharge, the tobacco film wascalendared and cooled to room temperature by utilizing a 3-roll stackedchill roller. Downstream from the chill roller the film was taken up ona rewind reel, incorporating Mylar between the film layers to preventadhesion. The tobacco film was placed in a container suitable forstorage.

The tobacco film was subsequently used in the manufacture of dissolvabletobacco containing pouches, as described herein. The film disintegratedslowly in the mouth, over a period of 2-4 minutes.

Example S Flavored Tobacco Film with Gelatin

TABLE S1 HPMC 35.95%  Gelatin 0.98% Starch 12.30%  Tobacco 23.64% Na₂CO₃ 1.47% Plasticizer 10.84%  Flavors 9.35% Sweetener 0.50%Surfactant 0.97% Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 13.84 g  HM100PA2208 (WolffCellulosics) 7.24 g HM4000PA2910 (Wolff Cellulosics) 1.21 g B700 (GrainProcessing Corporation) 7.63 g Gelatin 0.61 g Tobacco Powder (averageparticle size < 80 μm) 15.27 g 

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 0.91 g Propylene Glycol Monostearate 0.30 g Sodium LaurylSulfate 0.30 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 2.14 g Propylene Glycol 2.44 g Polyethylene Glycol 4002.14 g Mint Flavor 4.58 g Tobacco Flavor Modifier (Hagelin) 1.22 gSucralose Solution 25% (Tate & Lyle) 1.22 g

A total of 288.93 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 3 minutes. The resultant solutionwas transferred to a suitable container for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film dried to approximately4% moisture, was removed from the Mylar sheet, and cut intoappropriately sized units. A 1.0 inch by 1.25 inch unit of filmdissolved in the mouth in less than 30 seconds, releasing flavor,sweetener, and tobacco.

Example T Flavored Tobacco Film with Gelatin

TABLE T1 HPMC 32.01% Gelatin 4.92% Starch 12.30% Tobacco 23.64% Na₂CO₃1.47% Plasticizer 10.84% Flavors 9.35% Sweetener 0.50% Surfactant 0.97%Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 11.40 g  HM100PA2208 (WolffCellulosics) 7.24 g HM4000PA2910 (Wolff Cellulosics) 1.21 g B700 (GrainProcessing Corporation) 7.63 g Gelatin 3.05 g Tobacco Powder (averageparticle size <80 μm) 15.27 g 

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 0.91 g Propylene Glycol Monostearate 0.30 g Sodium LaurylSulfate 0.30 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 2.14 g Propylene Glycol 2.44 g Polyethylene Glycol 4002.14 g Mint Flavor 4.58 g Tobacco Flavor Modifier (Hagelin) 1.22 gSucralose Solution 25% (Tate & Lyle) 1.22 g

A total of 288.93 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 3 minutes. The resultant solutionwas transferred to a suitable container for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film dried to approximately4% moisture, was removed from the Mylar sheet, and cut intoappropriately sized units. A 1.0 inch by 1.25 inch unit of filmdisintegrated in the mouth in less than 30 seconds, releasing flavor,sweetener, and tobacco.

Example U Flavored Tobacco Film with Gelatin

TABLE U1 HPMC 27.09% Gelatin 9.85% Starch 12.30% Tobacco 23.64% Na₂CO₃1.47% Plasticizer 10.84% Flavors 9.35% Sweetener 0.50% Surfactant 0.97%Water 4.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM3PA2910 (Wolff Cellulosics) 8.35 g HM100PA2208 (WolffCellulosics) 7.24 g HM4000PA2910 (Wolff Cellulosics) 1.21 g B700 (GrainProcessing Corporation) 7.63 g Gelatin 6.11 g Tobacco Powder (averageparticle size <80 μm) 15.27 g 

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Na₂CO₃ 0.91 g Propylene Glycol Monostearate 0.30 g Sodium LaurylSulfate 0.30 g

In a third container were weighed the following ingredients:

MIX3 Glycerin 2.14 g Propylene Glycol 2.44 g Polyethylene Glycol 4002.14 g Mint Flavor 4.58 g Tobacco Flavor Modifier (Hagelin) 1.22 gSucralose Solution 25% (Tate & Lyle) 1.22 g

A total of 288.93 g of boiling water was weighed into a stainless steelcontainer. The water was stirred vigorously with an Arrow Model 1750high shear mixer. To the water was added MIX2. Stirring was continuedfor 30 seconds, at which point was added MIX1. Vigorous stirring wascontinued for 4 minutes. To the resultant solution was added MIX3.Vigorous stirring was continued for 3 minutes. The resultant solutionwas transferred to a suitable container for storage.

A portion of the resultant gel solution was poured onto a glass platewhich had previously been covered with an appropriately sized sheet ofMylar. The gel solution was drawn across the glass plate with adraw-down knife with a fixed gap of 20 mils. The glass plate was placedin a side-swept forced air oven (VWR model 1330FM), for 35 minutes,which had been set at 75° C. The resultant film dried to approximately4% moisture, was removed from the Mylar sheet, and cut intoappropriately sized units. A 1.0 inch by 1.25 inch unit of filmdisintegrated in the mouth in less than 30 seconds, releasing flavor,sweetener, and tobacco.

Tabs. Compositions of the invention may also be produced as tabs, suchas super fast disintegrate (about 15 seconds), fast disintegrate (lessthan 2 minutes), slow disintegrate (2-10 minutes), and chewable tabs.

Tabs may be sized as individual servings or smaller, a plurality ofwhich constitute an individual serving. Tabs sized as individualservings typically have dimensions of 5 mm to 15 mm. Smaller tabstypically range from 2 to 4 mm in diameter. Such smaller tabs may befabricated in a variety of colors or flavors, e.g., for simultaneousconsumption. Tabs may be shaped as a wafer, a convex or concave pellet,ovals, or any other shape known to the trade. Tabs may also be foamed toprovide faster dissolution or disintegration in the mouth. Tabs may alsobe layered to provide a variety of tastes or mouth feels as the tabdissolves or disintegrates. Tabs may also be coated to modify color ortaste or to provide mechanical strength for improved handling. In oneembodiment, a tab designed to disintegrate rapidly in water may becoated with a very thin water insoluble coating to provide protection tothe tab while a second, water soluble coating is applied.

Tabs may be fabricated from a dry mix, known as direct compression orfrom pregranulated materials by any forming method known in the art,e.g., via a press, injection molding, compression molding, injectionfoam molding, or compression foam molding.

Tab Examples

The following table shows exemplary ingredients for fabricating tabs ofthe invention.

TABLE V1 Ex. V Exemplary Fast Ex. W Ex. X Ex. Y Range (%) (%) Fast (%)Slow (%) Slow (%) Water soluble  0-70 0 3 23 0 polymer Tobacco  1-70 2720 27 30 Flavor Oil 0.5-4.0 2 1.8 2 2 Artificial 0.05-0.4  0.15 0.150.15 0.1 Sweetener Sugar  1-80 64 35 45.85 33.3 Maltodextrin  0-50 0 190 0 Disintegrant 0.1-15  6.35 3.0 — — Starch  5-80 0 17.35 — 50 ReleaseAgent 0.1-2.0 0.5 0.5 0.5 0.5 Emulsifier 0.1-5.0 0 0.2 0.5 0.1

Example Z Exemplary Chewable Tab

A chewable tab can be formed using the following ingredients:compressible sugar (40%); tobacco (20%); dextrose (25%); maltodextrin(13%); coloring agents (0.05%); flavor (1.35%); and magnesium stearate(0.60%).

Example AA Thermoplastic Tab

A thermoplastic tab can be formed using the following ingredients (inparts): hydroxypropyl cellulose (HPC) 54; tobacco 27; microcrystallinecellulose 10; propylene glycol 4; artificial sweetener 2; flavor 2; andstabilizer 0.2. The ingredients are dry mixed and fed to an extruderusing barrel temperatures necessary to melt the HPC (typically 340-370°F.). A rod of about ½ inch diameter is extruded and cut to sizesufficient to form a tab.

Example AB Tobacco Tab

TABLE AB1 Formulation of Tobacco Tab Ingredients % Dry Weight BasisTobacco Powder 25.00 Sweetener 32.11 Maltodextrin 40.22 Flavors 0.75Emulsifier 1.36 Na₂CO₃ 0.56 Total 100.00

TABLE AB2 Formulation of Binding Solution for Production of Tobacco TabIngredients Percent Water 45.00 Maltodextrin 53.05 Emulsifier 1.80Sweetener 0.15 Total 100.00Preparation of Binding Solution

Ingredient amounts, as noted in Table AB2, were weighed out intoseparate containers. Gum Arabic Pre-hydrated (emulsifier) was slowlyadded to the water and mixed under high shear agitation in a stainlesssteel vessel. After complete dissolution, M 585 maltodextrin (GrainProcessing Corporation) was added slowly to the water. Once M 585 wascompletely dissolved, the Sucralose sweetener (Tate & Lyle) was addedslowly and mixed thoroughly to ensure complete dissolution.

Formulary amounts of peppermint and spearmint flavors and Na₂CO₃ asnoted in Table AB1 were added to the binding solution. The entiremixture was homogenized for approximately 20 minutes at 9000-10000 RPMswith the aid of a homogenizer. The proper amount of binding solution touse was determined by the batch size and the ingredient percentagesshown in Table AB1. The homogenized solution was transferred into theflavor holding/pumping tank.

Preparation of Dry Ingredients

The formulary amounts of mannitol (sweetener) and tobacco powder (bonedry basis), as noted in Table AB1, were blended together and placed inthe product bowl.

Preparation of Vector Multiflo-15 Fluid Bed Chamber

A Vector Multiflo-15 fluid bed coater was used to apply the bindingsolution to the dry ingredient blend to form the final granulation. Themanual process was selected on the control panel computer. The machineoperating parameters, located in Table AB3, were loaded into theprogram:

TABLE AB3 Vector Multiflo-15 Fluid Bed Parameter Settings InletTemperature (Celsius) 60 Airflow (CFM) 150 Flowrate (G/Min) 125 FilterPulse Interval (Sec) 30 Post-Pulse Time (Sec) 60

The appropriate amount of binding solution to be sprayed on was alsoloaded into the program. The binding solution amount was determined bythe desired batch size to achieve the ingredient percentages shown inTable AB1.

Granulation Process

Once the dry ingredients were fluidized in the fluid bed chamber andachieved a temperature of 40-45° C., the binding solution was slowlysprayed onto the dry ingredients to form the granulation. The nozzlepressure was set at 22 psi and airflow at 200 CFM. The airflow wasincreased to ensure good product movement or fluidization in the fluidbed chamber. Once all the binding solution had been applied, the airflowwas reduced to 200 CFM. The process was stopped once the producttemperature reached approximately 43° C.

Preparation of Granulation for Forming Tabs

The granulated material was then sized through a 12-mesh screen. Themagnesium stearate (lubricant) was sized through a 40-mesh screen. Theformulary amount of magnesium stearate as noted in Table AB4 wascombined with the granulated material in a plastic bag and manuallyshaken for 2 minutes.

TABLE AB4 Formulation of Ingredients for Forming Tabs Ingredients % DryWeight Basis Granulated Material 99.50 Lubricant 0.50 Total 100.00Tab Forming Process

The granulated material plus lubricant was loaded into the hopper of thepress. The following parameters noted in Table AB5 were set on theVanguard VSP 8 Mini Rotary Press:

TABLE AB5 Parameters for Tobacco Tab Fast Disintegrate Slow DisintegrateParameters Settings Ranges Settings Ranges Fill Depth (MM) 8.0 11.311.3-11.4 Thickness (MM) 1.3 1.8 Principal Pressure (KN) 5.0 10.8-12.0Ejection Pressure (MM) 0.03-0.12

Fast disintegrate disintegrated in the mouth within 1 to 3 minutes. Slowdisintegrate disintegrated in the mouth between 5-8 minutes.

Example AC Tobacco Tab

TABLE AC1 Formulation of Tobacco Tab Ingredients % Dry Weight BasisTobacco Powder 25.00 Sweetener 34.11 Maltodextrin 38.58 Flavors 1.00Emulsifier 1.31 Total 100.00

TABLE AC2 Formulation of Binding Solution for Production of Tobacco TabIngredients Percent Water 45.00 Maltodextrin 53.04 Emulsifier 1.80Sweetener 0.16 Total 100.00

The procedures previously stated in Example AB1 for binding solutionpreparation were followed. Formulary amounts of peppermint and spearmintflavors as noted in Table AC1 and 45.00 grams of Na₂CO₃ were added tobinding solution. The remaining procedures for the make-up for thebinding solution, preparation of dry ingredients, preparation of VectorMultiflo-15 Fluid Bed Chamber, and granulation process were followed.

Preparation of Granulation for Forming Tabs

The granulated material and magnesium stearate were sized through theappropriate screens as previously stated. The formulary amount ofmagnesium stearate (0.75% for a fast disintegrate or 1.00% for a slowdisintegrate) was combined with the granulated material in a plastic bagand manually shaken for 2 minutes.

Tab Forming Process

The machine operating parameters noted in Table AC3 were set on theVanguard

TABLE AC3 Tab Forming Parameters for Tobacco Tab Fast Disintegrate SlowDisintegrate Parameters Settings Ranges Settings Ranges Fill Depth (MM)6.8 9.9 Thickness (MM) 1.1 2.0-2.1 Principal Pressure (KN) 6.9-7.23.8-4.0 Ejection Pressure (MM) 0.03-0.15

Example AD Tobacco Tab

TABLE AD1 Formulation of Tobacco Tab Ingredients % Dry Weight BasisTobacco Powder 25.00 Filler 30.00 Maltodextrin 42.15 Flavor 0.75Emulsifier 1.43 Sweetener 0.12 Na₂CO₃ 0.56 Total 100

TABLE AD2 Formulation of Binding Solution for Production of Tobacco TabIngredients Percent Water 45.00 Maltodextrin 53.06 Emulsifier 1.80Sweetener 0.14 Total 100.00

The procedures previously stated for binding solution preparation werefollowed. Formulary amounts of Cinnamon Flavor and Na₂CO₃ as noted inTable AD1, were added to the binding solution. The remaining proceduresfor the make-up of the binding solution, preparation of dry ingredients(lactose filler combined with tobacco powder), preparation of the VectorMultiflo-15 Fluid Bed Chamber, and the granulation process werefollowed.

Preparation of Granulation for Forming Tabs

The granulated material and magnesium stearate were sized through 12-and 40-mesh screens, respectively. The formulary amount of magnesiumstearate (0.50% for a fast disintegrate or 1.00% for a slowdisintegrate) was combined with the granulated material in a plastic bagand manually shaken for 2 minutes.

Tab Forming Process

The parameters noted in Table AD3 were set on the Vanguard VSP 8 MiniRotary Press:

TABLE AD3 Tab Forming Parameters for Tobacco Tab Fast Disintegrate SlowDisintegrate Parameters Settings Ranges Settings Ranges Fill Depth (MM)7.7 11.2 11.2-11.3 Thickness (MM) 1.1 1.7 1.7-1.8 Principal Pressure(KN) 5.7-6.0 3.8-4.0 Ejection Pressure (MM) 0.03-0.08 0.03-0.17

Example AE Tobacco Tab

The same procedures were followed for making a Tobacco Tab in Example ADexcept wintergreen flavor was used in place of cinnamon flavor.

Preparation of Granulation for Forming Tabs

The finished material was then sized through a 12-mesh screen. Themagnesium stearate was sized through a 40-mesh screen. The formularyamount of magnesium stearate (0.50% for a fast disintegrate or 0.75% fora slow disintegrate) was combined with the granulated material in aplastic bag and manually shaken for 2 minutes.

Tab Forming Process for Tobacco Tab

The parameters noted in Table AE1 were set on the Vanguard VSP 8 MiniRotary Press:

TABLE AE1 Tab Forming Parameters for Tobacco Tab Fast Disintegrate SlowDisintegrate Parameters Settings Ranges Settings Ranges Fill Depth (MM)8.1 12.0 12.0-12.1 Thickness (MM) 1.1 1.1-1.2 1.8 Principal Pressure(KN) 5.7 5.7-6.0 4.5 4.5-5.2 Ejection Pressure (MM) 0.03-0.09 0.04-0.19

Example AF Tobacco Tab with an Opaque, White Coating

TABLE AF1 Formulation of Tobacco Tab Ingredients % Dry Weight BasisTobacco 25.00 Filler 30.00 Maltodextrin 39.74 Flavor 0.75 Emulsifier1.35 Sweetener 0.10 Na₂CO₃ 0.56 Tobacco Flavor Modifier 2.50 Total 100

TABLE AF2 Formulation of Binding Solution for Production of Tobacco TabIngredients Percent Water 45.00 Maltodextrin 53.07 Emulsifier 1.80Sweetener 0.13 Total 100Preparation of Binding Solution

The procedures previously stated for binding solution preparation werefollowed. Formulary amounts of apple flavor, natural bitter blocker(Comax), and Na₂CO₃ as noted in Table AF1 were added to bindingsolution. The remaining procedures for the make-up of the bindingsolution, preparation of dry ingredients (lactose filler plus tobaccopowder), preparation of the Vector Multiflo-15 Fluid Bed Chamber, andthe granulation process were followed.

Preparation of Granulation for Tab Forming

The finished material was then sized through a 12-mesh screen. Themagnesium stearate was sized through a 40-mesh screen. The formularyamount of magnesium stearate (0.75% for a slow disintegrate) wascombined with the granulated material in a plastic bag and manuallyshaken for 2 minutes.

Tab Forming Process

The parameters noted in Table AF3 were set on the Vanguard VSP 8 MiniRotary Press:

TABLE AF3 Tab Forming Parameters for a Slow Disintegrate Tobacco TabParameters Settings Ranges Fill Depth (MM) 13.6 13.5-13.7 Thickness (MM)2.4 2.4-2.5 Principal Pressure (KN) 4.5-5.2 Ejection Pressure (MM)0.04-0.24Tobacco Tab Coating-Suspension Makeup

A 20% Opadry II aqueous solution was prepared as directed by themanufacturer and allowed to mix 45 minutes prior to coating.

Coating Process

Tabs (5.5-6.5 KG) were placed in the coating pan of a Vector/FreundHi-Coater pan coating machine and warmed until the exhaust temperaturereached 45° C. This was done with the pan running at less than 5 RPMs tominimize Tab attrition. Air at 75° C. and 100 CFM ran across the pan ata pan pressure of −0.5″ water.

Once the tabs reached temperature, the pan speed was increased toapproximately 15 RPMs and the Opadry coating suspension was applied at arate of 15-20 grams/minute. The suspension was continually mixed duringapplication to prevent the solids from settling. The spray was atomizedwith approximately 100 liters of air per minute at approximately 70 psi.The atomized spray was formed into a pattern using directional air portson the nozzle set at approximately 50 liters of air per minute atapproximately 70 psi.

Inlet air temperature was periodically increased or decreased tomaintain an exhaust temperature between 43 and 46° C.

Spraying was continued until desired amount of solids was applied tosatisfy formulary requirements which was typically around 3%, or untiltabs were visually satisfactory.

Example AG Tobacco Solid Disintegratable

The following ingredients were weighed out into individual containers:

Klucel EF (Hercules) 60 g Tobacco Powder 75 g Tobacco Flavor Modifier 6g Corn Syrup (65%) 45 g Sucrose 45 g B700 (Grain Processing Corp.) 51 gSucralose Solution 25% (Tate & Lyle) 3 g Propylene Glycol 3 g SodiumCarbonate 1.5 g Water 6 g Oil of Peppermint 4.5 g Water portion 1 (hot)120 g Water portion 2 (cold) 120 g

The 6 g of water was added to the sodium carbonate, and the mixture wasstirred. This mixture was allowed to stir until it was added to theother ingredients later in the process.

Water portion 2 (cold) was placed in an ice bath to chill while waterportion 1 (hot) was heated to 60° C. and transferred to a stainlesssteel container. The 60° C. water was stirred with an Arrow Model 1750high shear mixer and the Klucel EF gradually added to the water. Thissolution was stirred for several minutes. Water portion 2 (cold) wasthen added to the mixture. An ice bath was placed under the stainlesssteel container, and the mixture was stirred for 15 minutes.

After 15 minutes of stirring, the remaining ingredients were added tothe mixture one at a time. The mixture was thoroughly blended prior tothe addition of the next ingredient. The ingredients were added in thefollowing order: tobacco flavor modifier, propylene glycol, sucralosesolution, corn syrup, sodium carbonate solution, sucrose, tobaccopowder, B700, and oil of peppermint. Ice was added to the ice baththroughout the mixing process to keep the mixture cold. After allingredients were added, the mixture was stirred for an additional 10minutes.

The container was removed from the ice bath and the mixture wasdispensed in solid disintegratable portions onto wax paper and allowedto dry at room temperature for 24 hours. The solid disintegratables wereremoved from the wax paper and transferred to another sheet of wax paperto continue drying at room temperature. The desired hardness for thesolid disintegratables was achieved after 12 to 24 hours of continueddrying.

Example AH Tobacco Solid Disintegratable

The following ingredients were weighed out into individual containers:

HPMC 2910 HM E5/6 Bv (Celanese) 60 g Tobacco Powder 75 g Tobacco FlavorModifier 6 g Corn Syrup (65%) 45 g Sucrose 45 g B700 (Grain ProcessingCorp.) 39 g Sucralose Solution 25% (Tate & Lyle) 3 g Propylene Glycol 15g Sodium Carbonate 1.5 g Water 6 g Oil of Peppermint 4.5 g Water portion1 (hot) 120 g Water portion 2 (room temp.) 120 g

The 6 g of water was added to the sodium carbonate, and the mixture wasstirred. This mixture was allowed to stir until it was added to theother ingredients later in the process.

Water portion 1 (hot) was heated to 80° C. and transferred to astainless steel container. The 80° C. water was stirred with an ArrowModel 1750 high shear mixer, and the HPMC gradually added to the water.This solution was stirred for several minutes. Water portion 2 (roomtemp.) was then added to the mixture, and the mixture was stirred for 15minutes.

After 15 minutes of stirring, the remaining ingredients were added tothe mixture one at a time. The mixture was thoroughly blended prior tothe addition of the next ingredient. The ingredients were added in thefollowing order: tobacco flavor modifier, propylene glycol, sucralosesolution, corn syrup, sodium carbonate solution, sucrose, tobaccopowder, B700, and oil of peppermint. After all ingredients were added,the mixture was stirred for an additional 10 minutes.

The mixture was dispensed in portions onto wax paper and allowed to dryat room temperature for 24 hours. The solid disintegratables wereremoved from the wax paper and transferred to another sheet of wax paperto continue drying at room temperature. The desired hardness for thesolid disintegratables was achieved after 12 to 24 hours of continueddrying.

A similar product was made using the same formulation, mixing process,and dispensing process, but the solid disintegratables were dried in aforced air oven (VWR Model 1330FM) set at 32° C. for one hour. The soliddisintegratables were then removed from the oven and dried at roomtemperature for 24 hours. Additionally, solid disintegratables weredried in the forced air oven at 32° C. for 18 hours. A slightly hardersolid disintegratable with a dull finish was achieved with this dryingtechnique.

Example AI Multilayer Tab

Commercially available press equipment can be used to prepare tabs withtwo or more distinct layers. The composition of these layers can be thesame or different in composition. Individual layers can bedifferentiated by color, flavor, tobacco type, tobacco content,dissolution rate, and other similar characteristics. For example, onelayer could disintegrate very rapidly to release flavor or flavormasking ingredients. A second layer containing tobacco powder coulddisintegrate more slowly thereby gradually exposing the tobacco.

Shaped Parts. Tobacco compositions may also be formed into products thatare sufficiently rigid to be easily handled. These shaped products mayvary in physical properties and range from highly flexible to highlystiff parts. Such products may be formed into any shape and be dense orfoamed. These compositions typically have a moisture content of 2-50%,preferably 5-10%, of the finished part weight. Exemplary shapes includea tube, a toothpick, a stick, a twist, or a solid rod. Typically, ashaped part will be sucked or chewed on for an extended period of timeto release tobacco organoleptic components into the mouth. A shaped partmay or may not disintegrate orally. Parts that disintegrate may do soover a period of 1-60 minutes, preferably from 1-10 minutes.

Shaped parts may or may not be sized to fit entirely in the mouth.Compositions larger than the mouth may be partially inserted. Typicallythe largest dimension of a shaped part is 6 inches, more preferably 2.5inches.

Shaped parts may contain discrete regions, e.g., with each region havingthe same or different flavor or color or size or form of tobacco, e.g.,tobacco perceived as soluble. For example, a twist may containindividual strands, each having a different flavor or color or size orform of tobacco. As further examples, shaped parts may be prepared inmultistep processes in which molded or extruded parts are composed oflayers, two or more of which contain different flavors, colors, or sizesor forms of tobacco.

Shaped part compositions may be fabricated by any method known in theart, e.g., extrusion, compression molding, injection molding, impactforming, foam molding, blow molding, and overmolding. In addition,shaped parts may be based on water soluble or thermoplastic formats. Inone embodiment, an aqueous-based shaped part is fabricated by forming aviscous paste (e.g., via Hobart process) of the format, water, tobacco,and other ingredients and pressing the paste into a form, extrudingthrough a die, or forming a sheet from which shapes are cut. The cut orformed part may then be dried to the desired moisture level of from2-50%, preferably from 5-10% of the finished part weight for very rigidparts and from 10-50% for highly flexible parts. In another embodiment,the aqueous paste can be formed in a two stage extrusion process (e.g.,via a Wenger twin screw extruder) in which the format, water, tobacco,and other ingredients are blended in a mixing or pre-extrusion stage ofthe machine, and the resulting paste is fed directly to the twin screwextrusion element of the machine and is extruded through a die to form ashape, which is then dried to the desired moisture level. Athermoplastic-based shaped part is fabricated, for example, by mixingcomponents via a PK blender, high intensity mixer, pre-pelletizer, orgranulation (fluid bed or Hobart) process. The mixed components may thenbe extruded through conventional single or twin screw extruders to formshaped parts or the mixture can be fed into injection molding machinesor other thermoplastic processing machinery to form shaped parts.

Shaped Part Examples Example AJ Injection Molded Shaped Parts

The following table provides exemplary shaped parts to be formed byinjection molding.

TABLE AJ1 1 2 3 4 5 6 7 8 Ingredient % % % % % % % % Tobacco 47.98 45.5967.18 63.83 78.22 74.32 29.33 27.87 Low viscosity 48.02 45.62 28.8427.40 19.59 18.61 68.48 65.06 HPC Water 4 3.80 3.98 3.78 2.19 2.08 2.192.08 Propylene 4.99 4.99 4.99 4.99 glycol

Heating zones were Zone 1—300-340° F.; Zone 2—350-370° F.; Zone3—300-340° F.; mold temperature was ambient. Sufficient composition wasfed to the screw to equal one injection cycle; the material wasimmediately injected into the mold; the mold was opened after 10seconds; and the part was removed. The shaped part was a stepped colorchip, 2 inches by 3 inches by steps at ⅛^(th), ¼^(th), and ⅜^(th) inchthickness.

Example AK Compression Molded Shaped Parts

The following table provides exemplary shaped parts formed bycompression molding.

TABLE AK1 A B C D E F G Ingredient % % % % % % % Tobacco 26.47 25.0025.00 30.00 25.00 25.00 25.00 Corn starch 49.41 30.30 9.50 60.60 30.3056.60 Starch B-820 30.30 Maltodextrin 30.30 Low viscosity HPC 45.00Soluble fiber 30.30 30.30 Cinnamon 4.41 5.00 5.00 5.00 5.00 5.00 5.00Flavor oil 4.41 5.00 5.00 5.00 5.00 5.00 5.00 Sucralose 0.88 0.90 0.900.90 0.90 0.90 0.90 Sodium carbonate 2.65 2.50 2.50 2.50 2.50 2.50 2.50Glycerin 1.00 1.00 2.00 1.00 1.00 5.00 Propylene glycol 11.77

10-50 grams of water is added per 100 grams of dry compound—sufficientto soften the mix and enable it to pass through a pasta die mounted on amixer. The mold parameters are as follows:

TABLE AK2 Mold Temperature 220-280° F. Residence Time 5 seconds to 60seconds Toothpick mold cavity 5/32nds inch diameter by 2⅜^(th) lengthStick mold cavity ⅜^(th) inch diameter by 2⅜^(th) length Disc moldcavity ¾ inch diameter by ¼ inch depth

Longer residence times produced more rigid parts, as long as the steamwas allowed to freely vent during the expansion of the part. Additivesmay also be employed so that the shaped part remains flexible afterremoval from the tool. The parts containing a majority of low viscosityHPC formed excellent pieces if left in the tool for an extended time (40to 60 seconds). The inclusion of plasticizer increased the rate ofmoisture absorption from the atmosphere, which caused some parts tosoften over time.

When the mold cavities were completely filled with molding compound,dense and rigid parts were prepared. When the mold cavities were filledto about 75% of the mold capacity, the compound expanded under thepressure of expanding steam to form foamed parts which had goodrigidity, good flavor, and which disintegrated readily in the mouth.

Foaming can be accomplished in aqueous systems by incorporating asurface active agent (e.g., sodium lauryl sulfate) into the mix andbeating to incorporate air; foaming or aeration can also be achieved byintroducing a gas (e.g. nitrogen) to the aqueous system while thecomposition is under high shear. The aqueous system is then dried to thedesired moisture level to create a stable foamed composition. In oneembodiment, an aqueous composition is introduced to partially fill acompression mold; the mold is closed; the mold temperature is raisedabove the boiling point of water to form steam, which expands theaqueous composition to fill the void area and to create a foamed, shapedpart. For thermoplastic systems, foaming can be accomplished byincorporating water into the tobacco/format composition; the temperatureis raised to above the boiling point of water to form steam; and, as thetobacco composition exits a die, the steam expands to create a foamedstructure. In another embodiment, gas (e.g., nitrogen or carbon dioxide)is introduced into the molten, thermoplastic, tobacco composition priorto its discharge from an extruder resulting in a highly uniform foamstructure in the shaped tobacco composition. Other thermoplastic foamingprocesses well known in the art (e.g., injection foam molding) can beused to create foamed, tobacco compositions and shaped parts.

Example AL Exemplary Aqueous Shaped Parts

Tables AL1 and AL2 show exemplary ingredients for fabricating aqueousshaped parts of the invention. Sufficient water is added to form aviscous paste.

TABLE AL1 Exemplary (parts) Preferred Example Tobacco 1-80 30-50 54Flavor 0.5-4   2.5-3    3 Insoluble Fiber 4.5-36   22.5-27   27 WaterSoluble 1-50  5-20 10 CMC 7MF (medium Polymer viscosity)Filler/Disintegrant 1-50 10-30 30 microcrystalline cellulose Artificial0.05-5    0.1-2   0.2 Sucralose Sweetener Dispersant 0.1-20   0.1-2  0.2 Sodium Lauryl Sulfate

TABLE AL2 Exemplary (parts) Preferred Example Tobacco 1-80 20-50 27Flavor 0.5-4   1-3  1 Insoluble Fiber 4.5-36    9-27  9 Water Soluble1-50  5-25 18 low viscosity HPC Polymer Filler/Disintegrant 1-50 10-3010 microcrystalline cellulose Artificial 0.05-3    0.1-1   0.5 SucraloseSweetener Dispersant 0.1-20   0.1-2   0.2 sodium lauryl sulfate

Example AM Exemplary Thermoplastic Shaped Parts

Table AM1 shows exemplary ingredients for fabricating thermoplasticshaped parts of the invention.

TABLE AM1 Exemplary (parts) Preferred 1 2 3 Tobacco 10-80 25-80 76.6 5025 Plasticizer  1-20 1-20 3 propylene 4.6 propylene 5.6 propylene glycolglycol glycol Water Soluble 10-80 20-50 20 30 40 Polymer Filler  0-600-30 — 15 29 Stabilizer 0.1-0.5 0.2-0.4 0.4 0.4 0.4

Example AN Tobacco Rods

A tobacco rod is made from tobacco (54 parts); flavor (2); insolublefiber (28); CMC (10); artificial sweetener (0.2); and microcrystallinecellulose (30). Water sufficient to form a viscous paste (e.g., 140parts) is added, and the paste is suitable for processing through anextruder. A suitable extruder would be a Kitchen Aid mixer fitted with apasta extruder and die. The rod prepared from extrusion through a pastadie can then be used as the forming mandrel for a spiral winding machineand a tobacco containing film can be used to form a wrapping around thetobacco core.

Example AO Compression Molded Cinnamon Flavored Tobacco Stick

TABLE AO1 Tobacco 23.84% Starch 24.09% HPMC 4.97% Flavor 15.90% Filler19.27% Na₂CO₃ 2.98% Sweetener 0.99% Plasticizer 4.97% Water 3.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM100PA2208 (Wolff Cellulosics) 11.16 g B700 (Grain ProcessingCorporation) 55.77 g Cinnamon Powder 24.54 g Fibersol-2 (Matsutani)44.61 g Na₂CO₃  6.69 g Sucralose (Tate & Lyle)  2.22 g Tobacco Powder(average particle size <80 μm) 55.77 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Glycerin 11.16 g Cinnamon Flavor 11.16 g

MIX1 was added to the stainless steel mixing bowl of a Kitchen Aid standmixer. MIX2 was incorporated slowly to the mixture over a time period of3 minutes with the aid of a paddle attachment at a medium-low speed.Following this addition, 76.92 g of water was added to the mix in thesame manner. The resulting paste was allowed to rest at room temperaturefor a period of 5 minutes.

Following the rest period, the paste was fed through a ⅛ inch aperturestrand forming unit which had previously been attached to the KitchenAid mixer. The strands produced were cut to between 1½ and 2 inches inlength, and stored in suitable containers.

A set of platens with 2 inch by ¼ inch opposing mold cavities was heatedto between 300-330° F. A formed strand was placed in the lower cavity,and the mold was closed by means of a hydraulic press. The mold wasallowed to remain closed for a period of 30-60 seconds, providing ameans for cooking the starch component of the unit and the release of aportion of the volatile components.

The newly formed stick, measuring approximately 2 inches by ⅛ inch,comprised a smooth rigid outer layer, and a rigid foam-like inner mass.The unit disintegrated in the mouth over a period of 1-2 minutes.

Example AP Compression Molded Apple Flavored Tobacco Stick

TABLE AP1 Tobacco 23.84% Starch 24.09% HPMC 4.97% Flavor 6.45% Filler19.27% Na₂CO₃ 2.98% Sweetener 10.42% Plasticizer 4.97% Water 3.00%

The following ingredients were weighed and combined in a container ofsuitable volume:

MIX1 HM100PA2208 (Wolff Cellulosics) 11.16 g B700 (Grain ProcessingCorporation) 55.77 g Sucrose 22.29 g Fibersol-2 (Matsutani) 44.61 gNa₂CO₃  6.69 g Sucralose (Tate & Lyle)  1.11 g Malic Acid  2.22 gTobacco Powder (average particle size <80 μm) 55.77 g

The resultant mixture was mixed until homogeneous. In a separatecontainer were weighed the following ingredients:

MIX2 Glycerin 11.16 g Apple Flavor 12.27 g

MIX1 was added to the stainless steel mixing bowl of a Kitchen Aid standmixer. MIX2 was incorporated slowly to the mixture over a time period of3 minutes with the aid of a paddle attachment at a medium-low speed.Following this addition, 76.95 g of water was added to the mix in thesame manner. The resulting paste was allowed to rest at room temperaturefor a period of 5 minutes.

Following the rest period, the paste was fed through a ⅛ inch aperturestrand forming unit which had previously been attached to the KitchenAid mixer. The strands produced were cut to between 1½ and 2 inches inlength, and stored in suitable containers.

A set of platens with 2 inch by ¼ inch opposing mold cavities was heatedto between 300-330° F. A formed strand was placed in the lower cavity,and the mold was closed by means of a hydraulic press. The mold wasallowed to remain closed for a period of 30-60 seconds, providing ameans for cooking the starch and sugar components of the unit and therelease of a portion of the volatile components.

The newly formed stick, measuring approximately 2 inches by ⅛ inch,comprised a rigid outer layer, and a rigid foam-like inner mass. Theunit disintegrated in the mouth over a period of 1-2 minutes.

Example AQ Extruded Tobacco Sticks

TABLE AQ1 Tobacco 24.34% Starch 58.48% Na₂CO₃ 3.17% Plasticizer 6.34%Sweetener 0.79% Flavor 4.88% Water 2.00%

The following ingredients were granulated in a manner similar togranulations utilized for tab production, yielding a tobacco granulationwith an approximate moisture of 4.50%:

B700 (Grain Processing Corporation) 3327.1 g B825 (Grain ProcessingCorporation)  120.0 g Na₂CO₃  181.4 g Sucralose (Tate & Lyle)  45.4 gGlycerin  362.9 g Tobacco Powder (average particle size <80 μm) 1451.5 gWater 3473.0 g

The tobacco granulation was introduced to the feed section of aLeistritz Micro-18 Twin Screw Extruder 40:1 L/D, which had beenconfigured for co-rotating extrusion with a medium-shear screw design.Feed rates for the extrusion varied between 1-3 pounds per hour. Barrelzone temperatures varied between 75-100° F. Flavor application rateswere established at 5 percent of the process flow; hence cinnamon flavorwas incorporated to the process downstream of the granulation feed.Venting of volatiles from the extrusion melt was accomplished byincorporating a venting orifice prior to the discharge die of theextruder.

Solid tobacco sticks, with an approximate diameter of ⅛ inch, wereproduced by incorporating a strand die at the discharge end of theextruder. Upon discharge, the flexible tobacco strand was cooled to roomtemperature on an air-cooling conveyor and became rigid, and was cut toapproximately 2½ inches in length. The formed tobacco sticks were placedin a suitable container for storage. The stick disintegrated slowly inthe mouth over a period of 5-10 minutes.

Gels and Gel Beads. Compositions of the invention may also be made asgels or gel beads. The composition may contain a soluble or insolublegel containing tobacco. A gel may be used to encapsulate anothermaterial, or another material may encapsulate a gel. Gels may beconsumed in hydrated forms containing as much as 70% water. The gels mayalso be dried resulting in parts containing from 1 to 70% water. Theamount of water retained in the gel depends on the properties desired inthe finished product. It is possible to prepare tobacco containing gelsthat provide a wide range of organoleptic characteristics.

Exemplary gel formats for soluble and insoluble gels include kappacarrageenan, sodium alginate, carboxymethyl cellulose, gelatin, pectin,agar, and starches.

Soluble gels containing tobacco can be formed by dissolving the formatand at an elevated temperature, e.g., kappa carrageenan at 180° F., andadding the tobacco powder to this solution while continuing vigorousmixing. The hot mixture is then deposited into a mold. Gelatin providesa weak gel at room temperature but firmness and stability can beincreased by the addition of agar or starches. Other gelling formats maybe used in a similar manner.

Insoluble gels are formed by the addition of a cross-linking agent to apredissolved solution or slurry. The solution is deposited into a moldto form the desired shape and sets up through cooling and/or drying. Inmost cases, it is necessary to maintain the solution at a hightemperature, e.g., greater than 180° F., to prevent premature gelationprior to deposition into the mold. After the gel has set into its finalshape, the gel can be packaged as is or be further dried to a desiredwater content. Cross-linking agents include potassium ions forcarrageenan; calcium ions for alginates and low methoxy pectins; andtrivalent ions such as aluminum for carboxymethyl cellulose. Ininsoluble gels (i.e., those that do not orally disintegrate), tobaccoorganoleptic compounds may leach out of the gel as it is held or chewedin the mouth.

In one embodiment, gel compositions, e.g., beads, have a solid or liquidcenter. An exemplary solid center includes smokeless tobacco. Aninterior liquid may be aqueous, non-aqueous, or heterogeneous, dependingon the solubility characteristics of the encapsulating bead wall.Aqueous based liquids are typically encapsulated in a water-insolublegel that can be disrupted, either mechanically or chemically, in themouth. The encapsulating gel format may include a polymer and a crosslinking agent. Exemplary systems include carrageenan and a monovalentcation (e.g. potassium), alginate or pectin and a divalent ion (e.g.calcium), carboxymethyl cellulose and a trivalent ion (e.g. aluminum),and gelatin and gum arabic. The center may or may not include tobacco.

In another embodiment, a water soluble gel encapsulates a non-aqueousfilling, e.g., employing ethanol, glycol, vegetable oil, or mineral oil.The water soluble gel and/or the non-aqueous filling may contain tobaccoand other ingredients as described herein. Aqueous liquids may also beencapsulated in water soluble gels by the inclusion of additives, e.g.,sugars or salts, that sufficiently bind the available water in thefilling, thus, preventing the water in the liquid from dissolving theencapsulant. Gel encapsulants also include both hard and soft standardgelatin capsules, which can be filled with liquids or solids.

The center of these gel compositions may or may not include tobacco,e.g., as a tobacco slurry. The gel encapsulant also may or may notinclude tobacco. An exemplary solid center includes smokeless tobacco.The center may also include a color, sweetener, flavor, or flavormasking agent, which may be the same or different from that of the gelencapsulant. The rate of disintegration for the gel encapsulant andcenter may also be the same or different. Gels with centers typicallyhave a largest dimension of at most 10 mm, e.g., at most 5 mm. Gel beadswith liquid centers may be made by introducing droplets of atobacco/format mixture into a solution causing gelation of the outersurface of the gel bead and retaining the liquid center. Beads can beformed using commercial processes developed by the Morishita JintanCompany and others and referred to generically as “seamless liquidencapsulation” or “seamless capsule technology.” In addition, widelyused methods for forming gels of all types including beads have beendeveloped by the suppliers of alginate, carrageenan, and pectin polymersand are well known in the art. The amount of gelation may be controlled,thereby controlling the thickness of the gel encapsulant wall, byvarying the concentration of the format, the concentration of thecross-linking agent (e.g., salt), the temperature of the solidifyingsolution, and the residence time of the gel bead in the solidifyingsolution. The solution may contain a cross-linking agent or may inducegelation by other means, e.g., a temperature change.

Solid gels may be soluble or insoluble. For solid gels, the tobacco andformat, with or without additives, are typically mixed, and the formatis allowed to gel. Soluble gels can be obtained by using a self gellinggum, such as gellan gum or kappa carrageenan, or by using a polymer,e.g., gelatin, that sets by a change of temperature. Insoluble solidgels are prepared using a cross linking agent. Such soluble andinsoluble gels may be made by introducing droplets into an oil bath,e.g., canola oil, or into an aqueous, cross-linking bath to form aspherical shape. They may also be made to pass through the oil into awater based cross-linking solution. Gels may also be made in molds ormay be die cut from sheets.

In another embodiment, a gel composition is supplied as a dry mixture offormat, cross-linking agent (e.g., salt), and tobacco, e.g., in powderform, that is solvated by the consumer prior to use. Solvation causesthe gel composition to form a solid, which may be placed in the mouth.Typically, the user places the dry mixture of gel ingredients in a moldand adds solvent, which may be aqueous or non-aqueous. The mixture thenquickly hydrates, thereby forming a gel which solidifies in the shape ofthe mold. The solvating liquid may be used to impart flavor or othertaste or mouth feel characteristics to the composition. Alternatively,the consumer may place the dry mixture in the mouth for salvation. Thesolvent may impart flavor or color to the composition.

Gel Examples Example AR Gel Beads

100 g of 4% solution of CMC-7MF and 20 g tobacco are combined. Drops aredeposited into a 5% solution of water soluble, edible trivalent salt(e.g., AlCl₃ or Al₂(SO₄)₃). The surface of droplets is then dried withair drying or gentle oven drying.

100 g of 2% kappa carrageenan and tobacco are combined and heated to180-190° F. Drops are deposited into a cool solution of 5% KCl.

100 g of 4% medium viscosity sodium alginate and tobacco are combined at150-170° F. Drops are deposited into a cool solution of 5% edibledivalent salt (e.g., CaCl₂ or Ca citrate).

Beads containing gelatin walls and tobacco slurry centers can beprepared by depositing drops of a cold tobacco slurry (e.g. 60° F.) intoa slow moving stream of a dilute, warm gelatin solution (e.g. 130° F.).The warm gelatin coats the outside of the cold droplet and as thegelatin cools and solidifies, it forms a wall of gelatin around theliquid center.

Beads are retrieved from the solution by standard means.

Example AS Orally Disintegrable Solid Gels

Combine 10 g gelatin and 90 g water and heat to 140° F. to dissolvegelatin. Add 20 g tobacco and pour into a mold. Strength of the gel canbe increased by substituting 6 g of gelatin and 4 g of agar and heatingto 190° F. to dissolve.

Table AS1 shows exemplary ingredients for fabricating orallydisintegrable gels of the invention.

TABLE AS1 Example 1 (parts) Example 2 (parts) Gelatin 8 6 Tobacco 40 40Flavor 2 2 Insoluble Fiber 18 18 Sweetener 0.2 0.2 Agar 4 6 SolubleFiber 15 15 Preservative 0.1 0.1 Water 200 200

Example AT Exemplary Insoluble Solid Gels

The following tables and descriptions show exemplary ingredients forfabricating insoluble gels of the invention, i.e., gels that do notorally disintegrate.

TABLE AT1 Carrageenan Gels Parts Kappa Carrageenan 8 Water 240 Tobacco54 Sweetener 0.5 Soluble Fiber 27 KCl 1.5

The composition is cast at 180° F. after adding KCl and mixingthoroughly.

TABLE AT2 Alginate Gels Parts Sodium Alginate 10 Water 240 Tobacco 54Sweetener 0.5 Soluble Fiber 27 CaCl₂ 1

The composition is cast after adding CaCl₂ at 180° F.

TABLE AT3 Carboxy Methyl Cellulose Gels. Parts CMC-7MF 10 Water 240Tobacco 54 Sweetener 0.5 Soluble Fiber 27 Al₂(SO₄)₃ 1

The composition is cast after adding Al₂(SO₄)₃ at 180° F.

Example AU Soluble Gels

416 grams of aqueous 3.9% kappa carrageenan and 51.0 grams of tobaccowere combined. The solution was heated to 180° F.-190° F. with stirring,and then the solution was deposited into a mold of the desired shape.Upon cooling, the resultant solid form was removed from the mold anddried to the desired tobacco concentration and gel consistency.

In an alternative process, to a 1000 ml stainless steel containerequipped with an overhead mixer, mixing bar and hotplate was added 400ml of water at greater than 200° F. The water was continuously stirredand heated, and 16.0 g of kappa carrageenan (Gelcarin GP 812, FMCBiopolymer) was added over 2 minutes. The resulting mixture was stirredfor an additional 20 minutes, or until all kappa carrageenan wasdissolved, then tobacco was added to the homogeneous solution, and theresulting mixture was stirred for an additional 2 minutes whilemaintaining an optimal temperature of 180° F. To this solution was added0.8 g powdered Sucralose and 7.0 g cinnamon oil (Wixon Industries) withvigorous stirring. Following an additional 1 minute of stirring, theresulting mixture was quickly transferred via pipette (inner diameter0.5 cm) to Teflon-coated metal molds to obtain the desired shape. Aftercooling to room temperature, the resulting gels were removed from themolds and air dried at room temperature for 1 h to several days untilthe desired consistency of the gels was obtained.

TABLE AU1 Carrageenan Gels Amount parts Kappa Carrageenan 16 Water 400Tobacco 51 Sweetener 0.8 Cinnamon Oil 7.0

Example AV Soluble Gels

100 grams of aqueous 20% gelatin and 33 grams of tobacco were combined.The solution was heated to 140° F.-150° F. with stirring, and then thesolution was deposited into a mold of the desired shape. Followingrefrigeration for a few minutes to a few days depending on desiredfirmness, the resultant solid form was removed from the mold and driedto the desired tobacco concentration and gel consistency.

In an alternative process, to a 400 ml stainless steel containerequipped with an overhead mixer, mixing bar and hotplate was added 80 mlof water at 140° F. The water was continuously stirred and heated, and20.0 g of Gelatin (Type A 250 Bloom 40 Mesh, Gum Technology) was addedover 2 minutes. The resulting solution was stirred for 5 minutes oruntil the gelatin was dissolved, then 33 g of tobacco was added inportions over 2 minutes. The resulting mixture was stirred for anadditional 1 minute, then 0.3 g powdered Sucralose and 1.0 g of oil ofpeppermint (rectified, Blend SX 0910001, Essex Labs) were added, and themixture was vigorously stirred for an additional 1 minute whilemaintaining a temperature of 140° F. The resulting mixture wastransferred via pipette (inner diameter 0.5 cm) to Teflon-coated metalmolds to obtain the desired shape. After cooling to room temperature,the resulting gels were removed from the molds, and the gelatin was setby refrigeration at 40° F. for 1 hour to several days depending ondesired firmness of the finished piece.

TABLE AV1 Gelatin Gels Amount parts Gelatin 20 Water 80 Tobacco 33Sweetener 0.3 Peppermint Oil 1.0

Example AW Gel Beads

A solution of 4% sodium alginate (Keltone LV, International SpecialtyProducts) was prepared by adding 12 g sodium alginate to 288 g of waterheated to boiling, followed by stirring and continuous heating of wateron a hot plate for 30 minutes or until the solution was homogeneous(stock solution A). A second solution of 0.50 M disodium hydrogenphosphate was prepared by dissolving 33.5 g disodium hydrogen phosphateheptahydrate in 200 ml of water with warming and stirring of theresulting mixture until the salt was dissolved, followed by adjustingthe solution to 250 ml with water. To 100 g of aqueous 0.50 M disodiumphosphate was added 20 grams of tobacco and the resulting solution wasstirred for 5 minutes (stock solution B). To 50 g of the resultingtobacco slurry (stock solution B) was added 50 ml of aqueous 4% sodiumalginate (stock solution A), and the resulting mixture was stirred for 5minutes. To flavor, 0.20 g of powdered Sucralose and 0.80 g of oil ofpeppermint (rectified, Blend SX 0910001, Essex Labs) were added to theresulting tobacco/sodium alginate slurry (solution C), and the mixturewas stirred for 2 minutes.

To prepare gel beads from solution C, a solution of aqueous 5% CaCl₂ wasprepared by adding 5 g of CaCl₂ to 95 g of water with stirring until thecalcium chloride was dissolved (solution D). Solution C was then addeddrop by drop to solution D by pipette from a height of 10 inches. Theouter coat of each droplet solidified upon exposure to solution D,forming a solid gel-like outer coat with a liquid center that sank tothe bottom of the calcium chloride solution. The gel beads were allowedto remain in the calcium chloride solution for 2-4 minutes, removed, andallowed to air dry for several minutes.

Amount parts Solution A Sodium alginate 12 Water 288 Solution B Disodiumhydrogen phosphate 13.4 heptahydrate Water 86 Tobacco 20 Solution CSolution A 50 Solution B 50 Sucralose 0.2 Oil of peppermint 0.8 SolutionD Calcium chloride 5 Water 95

Consumable Units. Compositions of the invention may also be fabricatedas consumable units. These units may be packaged as edible or inediblematerials. In one embodiment, the consumable unit includes tobacco(e.g., smokeless tobacco) or a tobacco composition, e.g., flakes, tabs,beads, granules, or other tobacco composition as described herein, and awrapping, e.g., a pouch. The wrapping, in one embodiment, may act as anadhesive to hold the composition together, e.g., to hold a plurality oftabs, beads, flakes, etc. together. Alternatively, the wrapping mayenclose the composition, e.g., loose tabs, beads, flakes, etc. Thecomposition may also include a liquid, e.g., a tobacco slurry. Thewrapping may or may not be orally disintegrable. Orally disintegrablewrappings may be used to enclose aqueous or non-aqueous liquids. When anaqueous liquid is employed with a water soluble wrapping, the liquidincludes an agent to prevent dissolution of the wrapping. Exemplaryagents include sugars, salts, and other hydrophilic agents capable ofbinding water sufficiently to reduce water activity to a level at whichthe water is no longer available to interact with and dissolve the watersoluble wrapping. The wrapping may also enclose a moldable tobaccocomposition that conforms to the mouth or holds its shape in the mouth.In one embodiment, an orally disintegrable wrapping encloses smokelesstobacco, e.g., dry snuff or tobacco, that is perceived as soluble (e.g.,less than 80 .mu.m particle size). Orally disintegrable smokelesstobacco compositions may be introduced to consumable portion packs whichhave been formed on continuous thermoforming or horizontalform/fill/seal equipment or other suitable packaging equipment usingedible films (which may or may not contain tobacco) made in accordancewith the subject technology. Consumable units may also contain two ormore, individually wrapped portions of tobacco, e.g., all containedwithin a larger package, one containing the other portions, or none ofthe portions contained with another. When multiple portions are used,any two may have the same or different flavor, color, form of tobacco,or rate of disintegration.

Exemplary wrapping materials include films formed from film compositionsbased on formats such as HPMC, CMC, pectin, alginates, pullulan, andother commercially viable, edible film forming polymers, such as thosedescribed herein. Other wrapping materials may include pre-formedcapsules made from gelatin, HPMC, starch/carrageenan, or othercommercially available materials. Such wrapping materials may includetobacco as an ingredient. Wrappings which are not orally disintegrablemay include woven or nonwoven fabrics; coated or uncoated paper; or ofperforated or otherwise porous plastic films. Wrappings may also becolored. Exemplary consumable units include those formed by any methodused in commercial packaging, e.g., blister pack and stik-pak (e.g. asmall package formed on a vertical form/fill/seal packaging machine).

Consumable Unit Examples

The following description provides exemplary ingredients for fabricatingconsumable units of the invention.

Example AX Films or Capsules Encapsulating Beads, Powders, Tabs, Etc

Any of the compositions described herein can be encapsulated with a filmor capsule. The encapsulant may provide color, stability (e.g., duringstorage, handling or consumption), or organoleptic properties (e.g.,flavor, sweetness, smell, or mouth feel). The encapsulant may alsocontain tobacco.

A vacuum forming tool is constructed which has a series of cavitieswhich are shaped as circles with diameter of ¾^(th) inch and depth of3⅜^(th) inch. Films as described herein are prepared with and withouttobacco as an ingredient. These films are introduced to a vacuum formingmachine with a vacuum forming tool. The films are placed over heatingelements and warmed to a temperature of 200° F. The films are thenquickly placed on the vacuum forming tool, and a vacuum is pulled todraw the film into the cavities. The films are then cooled to set theshapes. Tobacco powder is then introduced into each cavity. A secondsheet of film prepared with or without tobacco is selected and coated(by wiping the surface of the film with a wet felt) with a thin layer ofwater to create a sticky, adhesive surface. The sticky surface is placedon top of the formed sheet wherein each cavity is filled with a tobaccoproduct. The sheets are pressed together to form closed consumableunits. Each cavity is then cut out of the vacuum formed sheet to createindividual units. A unit is placed in the mouth wherein the filmdisintegrates and disperses the tobacco in the oral cavity.

Example AY Tobacco Particles in a Water-Soluble Bag

Smokeless tobacco particles or powder, e.g., snuff, may be placed in awater-disintegrable bag. When placed in the mouth, the bag disintegratesafter a specified period of time. The bag may contain a single servingof tobacco. It may also contain additional additives as describedherein. The tobacco may also adhere to itself as a moldable plug oncethe wrapping disintegrates.

The disintegrable bag may be formed using films such as those describedherein. The film can be formed into a bag using commercially availablepackaging equipment such as vertical form/fill/seal machines (e.g. stickpack machines), horizontal form/fill/seal machines, flow wrappers,thermoformers (blister pack machines), and other equipment common to theart.

Example AZ Tobacco Particles in Film/Fabric Laminations

Smokeless tobacco particles or powder may be placed in a bag that isformed from an open or highly porous wrapping material, e.g., fabrics,paper or plastic films, which has been laminated to a water-solublewrapping film. The water-soluble film layer provides protection for thetobacco contents and prevents the tobacco from sifting through theopenings of the insoluble material during storage and handling. Once thebag is placed in the mouth, the water-soluble film layer dissolves ordisintegrates.

Example BA Film Pouches Containing Tobacco

Films as described herein in Film Examples N, O, P, and Q were used tomanufacture tobacco containing pouches. Individual units approximately 1inch by 1¼ inches were cut from each sheet of manufactured film. Theunit was folded over lengthwise and heat-sealed using a Clamco Model210-8E impulse sealer. One end of the formed unit was also sealed in thesame manner. A flavored tobacco granulation was fed to the interior ofthe formed pouch, and the final seal was made as described to seal thepouch. The tobacco containing pouch disintegrated in the mouth between20 seconds and 1 minute, releasing the contents of the pouch.

Insoluble Matrices. Tobacco may also be coated onto or entrapped withinan insoluble matrix. Tobacco can be dispersed to form a slurry in anaqueous solution of a format, as when forming a film; this slurry can becoated on to an insoluble matrix or can be used to saturate a porousinsoluble matrix. The slurry may then be converted into a soluble orinsoluble gel or it may simply be dried to form a coating. When aportion of this coated/saturated insoluble matrix is placed in themouth, leaching of organoleptic components occurs through dissolution,chewing, or other means. In one embodiment, tobacco in a format isintroduced into a porous matrix, e.g., an open. cell polyurethane foamor a high loft polyester nonwoven fabric. The insoluble matrix may beplaced wholly in the mouth, or it may be disposed on a stick or otherhandle, which remains partially outside the mouth during consumption. Inanother embodiment, tobacco in a format is blended with an incompatibleliquid, e.g., a dispersion of carnauba wax in water, deposited in amold, and quickly cooled to cause a phase separation such that thetobacco slurry is disposed within a waxy structure. These matrices mayalso be chewable.

Formats for use in retaining the tobacco in the insoluble matrix includeany of the film forming polymers described herein; any of the gellingsystems described herein and any of the coating materials describedherein.

Insoluble Matrix Examples Example BB Polyurethane Foam A

A film forming composition which contains finely ground tobacco asdescribed herein is used to saturate a piece (e.g., 12 inches by 12inches by 1 inch) of open cell polyurethane foam (Stephenson & Lawyer,Inc. Grand Rapids, Mich.). The saturated foam is placed on a metal trayand is put into an air circulating laboratory oven preset at 175° F. forone hour. When the foam is removed from the oven, the tobacco containingcomposition has dried to form a coating that uniformly covers all theinterstices of the polyurethane foam. The coated foam is cut into piecesof a size (e.g., 1 inch by 1 inch by 1 inch) suitable to place in themouth. After use, the polyurethane foam is removed from the mouth anddiscarded.

Example BC Polyurethane Foam B

A sodium alginate and calcium salt gel composition containing finelyground tobacco as described herein is used to saturate an open cellpolyurethane foam (e.g., 12 inches by 12 inches by 1 inch). The alginategel is maintained at a temperature of 180° F. to prevent prematuresetting of the gel. The hot alginate gel is poured on to thepolyurethane foam, which is placed on a metal tray and then quicklycooled in a refrigerator at 40° F. to set the gel. The foam is thenplaced in a laboratory oven preset at 175° F. for 10 minutes to surfacedry the gel and to reduce moisture content to 50% based on dry weight ofthe gel. The partially dried gel fills voids in the polyurethane foam.The foam is cut into pieces and is placed in the mouth. A furtherexample of gels in an insoluble matrix is obtained by drying the gel toa lower moisture content (e.g., 10% based on dry weight of the gel). Thetobacco containing gel exhibits a firm, rubbery texture within the foammatrix and rehydrates slowly when placed in the mouth and chewed. Afteruse, the polyurethane foam is removed from the mouth and discarded.

Hollow Shapes. As discussed above, films or thin sheets of material maybe wrapped, extruded, blow molded, or otherwise shaped to form tubes,straws, or other hollow shapes. Exemplary film or sheet materials aredisclosed in the film section herein. Such hollow shapes may be singleor multilayer. When multiple layers are used, some may contain tobaccowhile others may contain colors, flavors, sweeteners, or other compoundsas described herein. Different layers may also be employed for stabilityduring handling or to control disintegration during consumption. Aspiral wrapped hollow shape, e.g., tube or straw, may require anadhesive (e.g., CMC or guar) to keep from unraveling. The layers in amultilayer hollow shape may contain the same or different color orflavor, and such layers may disintegrate at the same or different rates.As with films, tobacco may also be disposed within one or more layers ormay be disposed between layers in a sandwich arrangement. The hollowshape may also include a disintegrant to hasten disintegration.

The compositions described above may be hollow or filled. The fillingmay include tobacco, a flavor, sweetener, flavor masking agent, or acolor. The flavor or color of the filling may be the same or differentthan the hollow shape. The filling is typically a gel (solid orflowable) but may also be mechanically rigid or may be composed of apowder or other product form. Exemplary filling materials include gelsas described herein. A hollow shape may also be filled with acomposition that disintegrates more rapidly than the shape, e.g., toprovide tobacco at different times based on the rate of disintegration.

In one embodiment, a tobacco core (e.g., formulated with tobacco and aformat) can be extruded from a single or twin screw extruder into acoextrusion die. In a separate single or twin screw extruder, a watersoluble, thermoplastic outer layer (e.g., formulated with a format and aflavor) can be introduced to the coextrusion die to create a coated rod.A typical thermoplastic outer layer can be provided with a formulationbased on hydroxypropyl cellulose (HPC) which is extruded at atemperature between 220-370° F. In addition, a rigid extruded tobaccorod may become a core which is encased in a wrapped film.

In one example, a thermoplastic formulation containing hydroxypropylcellulose, tobacco, flavor, and sweetener can be blow molded to form ahollow shape.

In another example, films as described herein were additionally used tomanufacture spiral-wound straws and/or sticks. Strips of filmapproximately 10 inches by ¾ inch were cut from each sheet ofmanufactured film. A strip of paper of equal size was cut and woundspirally around a 3/16 inch diameter stainless steel mandrel. The paperwas secured about the mandrel with tape on each end. A strip of film waswound spirally about the paper in the same fashion, overlapping eachspiral by 1/16 inch. At each overlap the film strip was glued to itselfwith a 30% solution of gum arabic. The process was repeated with twoadditional plies of film. The mandrel and newly formed spiral-wound filmstraw/stick was placed in a side-swept forced air oven at 75° C. (VWRmodel 1330FM) for 15 minutes to dry. Upon removal from the oven, thespiral-wound straw/stick was removed from the mandrel, and the paper“core” removed from the interior of the straw/stick. The resultantstraw/stick was cut into various sizes.

For example, spiral-wound straw/stick products were prepared usingtobacco containing films as described in Example N. Flavored TobaccoFilm for Sticks/Wraps/Pouches/Vacuum Forming. Straw/stick productscontaining one layer, two layers and three layers of Example N filmswere prepared as described. When placed in the mouth, the straw/stickdisintegrated gradually over a period of 1 to 5 minutes.

In another example, straw/stick products were prepared using two layersof film as described in Example N. A third layer of film, prepared asdescribed in Example O. Flavored/Colored Film for Sticks/Wraps/Pouches,was provided on the top or outside of the straw/stick. The film fromExample O was red in color, cinnamon flavored and did not containtobacco. This straw/stick, when placed in the mouth, disintegratedgradually over a period of 1 to 5 minutes

In another example, straw/stick products were prepared using threelayers of film as described in Example P. Peach Flavored Film forSticks/Wraps/Pouches. The film from Example P contained tobacco powderand peach puree. The straw/stick was prepared as above. The straw/stickdisintegrated gradually over a period of 1 to 5 minutes.

In yet another example, straw/stick products were prepared using threelayers of film as described in Example N and Example Q. One layer oftobacco containing film prepared in Example N was used. A second layerof opaque, white film prepared as in Example Q was wound over the firstlayer of film and offset by ⅛^(th) inch. A third layer of tobaccocontaining film as prepared in Example N was wound over the second layerand again was offset by ⅛^(th) inch. The affect was to provide aspiral-wound straw/stick with a striped appearance. The straw/stick,when placed in the mouth, disintegrated gradually over a period of 1 to5 minutes.

In another example, hollow tobacco straws, with diameters ranging from ⅛to ¼ inch, were produced by methods similar to those employed in ExampleAQ of Shaped Parts; however, a tube die was employed in the manufactureof the straw. The straw(s) disintegrated slowly in the mouth over aperiod of 5-10 minutes. Similar articles may be manufactured with afilling, with methods known in the art (i.e. co-extrusion).

D. Modifications

Any tobacco composition described herein may be modified in variousways. For example, a composition may be coated in single or multiplelayers. Such coatings are employed, e.g., for handling, disintegrationrate, taste, and color. Exemplary coatings include HPMC. Coatings ordecorative patterns may be applied to the surface of the film usingprocesses known in the art, e.g., spraying, brushing, roll coating,doctor bar casting, slot coating, extrusion coating, hot meltdeposition, depositing particles or flakes, and other typical methods.Coatings may be matte or glossy. A coating may contain a color, flavor,sweetener, or flavor masking agent, as described herein. The color,flavor, sweetener, or flavor masking agent in the coating may be same ordifferent as the underlying composition. In addition, multiple coatingsmay also contain the same or different color, flavor, sweetener, orflavor masking agent. The coating may also disintegrate at a differentrate than the underlying composition. For example, a coating maydisintegrate faster than the underlying composition to provide a burstof flavor or other organoleptic components. An orally disintegrablecoating may also be placed on a composition that does not disintegrateorally. A coating that does not disintegrate orally may be placed on acomposition that disintegrates orally, and such a coating may beremoved, e.g., by chewing. Coatings may also be employed to preventevaporation of volatile components in a composition and to preventmechanical maceration of a composition prior to use. A coating may alsocontain tobacco.

Patterns may also be printed on the surfaces of compositions. Printingpatterns also encompasses dusting or sprinkling compounds on the surfaceof a composition. The pattern may be random or in a design, e.g., alogo. All printing processes known in the art, e.g., offset,flexographic, gravure, ink jet, laser, screen printing, and othertypical methods may be used. The printed pattern may or may not containa color, flavor, sweetener, or flavor masking agent, as describedherein. The color, flavor, sweetener, or flavor masking agent in thepattern may be same as or different from the underlying composition. Inaddition, multiple patterns may also contain the same or differentcolor, flavor, sweetener, or flavor masking agent. The printed patternmay also contain tobacco, e.g., up to 1-99%, preferably 10-50%. Such apattern may contain more tobacco, percentage-wise or in an absolutesense, than the underlying composition.

Flakes may also be added to compositions described herein. Flakes may bemixed into the composition, may be placed within a void in thecomposition, or may be placed on the surface, e.g., and adhered by acoating. Flakes may or may not contain a color, flavor, sweetener, orflavor masking agent, as described herein. The color, flavor, sweetener,or flavor masking agent in the flakes may be same or different as theunderlying composition. In addition, multiple flakes may also containthe same or different color, flavor, sweetener, or flavor masking agent.Flakes may also contain tobacco, e.g., up to 99%, preferably up to 50%.Flakes may be made by standard film forming technology as describedherein. Flakes may contain more tobacco, percentage-wise or in anabsolute sense, than the underlying composition.

Once the printed, coated, or decorated film has been prepared, anadditional layer of film may be applied to cover, protect and seal theprinted, coated or decorated surface.

Compositions of the invention may be shaped in various forms, e.g.,plants and geometric shapes (e.g., round, square, rectangular,triangular, oval, octagonal, and the like). In addition, compositionsmay contain a pattern in relief (positive or negative) on the surface.Such a pattern may be a design, such as a logo.

Composite compositions, i.e., compositions including two or more of thedifferent types of products described herein, are also contemplated bythe invention. For example, a shaped part may contain regions of gelcompositions, e.g., having a variety of flavors. In another example, atab may be surrounded by a gel. Composite compositions may also havedifferent rates of disintegration.

E. Packaging

Individual compositions will be packaged as appropriate for the contentsof the composition. Preferably, the compositions are stored in awaterproof case and are stable between 40 and 120° F. Compositions aretypically dry, flexible, and non-adhesive while in storage.Alternatively, compositions may be packaged using non-stick barriers,e.g., plastic film or paper, between servings. Compositions may also beprovided in a bulk form, from which individual servings are separated.

In another embodiment, the package is water impermeable and waterinsoluble, and tobacco, e.g., in liquid, slurry, or flowable gel form,is disposed within the package, e.g., a squeezable plastic package, abellows, or a spray bottle, and is capable of being dispensed into themouth from the package. The bellows may be compressed for oral use.Solutions or slurries are prepared for use in a plastic bellowscontainer or other similar consumer packaging containers wherein theliquid is injected into the mouth by squeezing the package. Thixotropicpolymers are combined with tobacco and other ingredients to preparehigher viscosity solutions suitable for use in other containers. Tobaccoparticles can be of greater size, but must still be small enough to passthrough the orifice of the container. For spray bottles, a stabletobacco slurry is contained in the bottle; tobacco particles are sizedto be able to pass through a spray nozzle without blocking the orifice;and the tobacco slurry is sprayed directly in the oral cavity. Liquidsprays are prepared by dissolving a thixotropic polymer such as xanthan,gellan or dextran in water and suspending tobacco particles in a lowviscosity (e.g., <50 centipoise) solution. Other compounds, such asflavor, sweetener and dispersant, can be added to the solution. Thetobacco particles are ground to a particle size (e.g., <80 microns) topermit the homogeneous solution to pass through the orifice of a spraybottle. Other packages may be otherwise squeezed or used to expel thetobacco into the oral cavity.

F. Solutions

The following tobacco solutions may be included in any compositiondescribed herein.

Example BD Sprayable Solution

A solution is prepared by mixing 0.2 grams of xanthan (Kelzan from C. P.Kelco) in 78.6 grams of cool water with vigorous mixing for 30 minutes.To this solution is added 20 grams of finely ground tobacco, 0.2 gramsof sucralose, and 2 grams of cinnamon flavor while continuing to mixvigorously. The solution viscosity is adjusted with water to a viscosityof 50 centipoise.

Example BE Thick Solution

A solution is prepared by mixing 1 gram of xanthan (Kelzan from C. P.Kelco) with 76.8 grams of cool water while mixing vigorously for 30minutes. To this is added 20 grams of fine tobacco, 0.2 grams ofsucralose and 2 grams of cinnamon flavor while continuing to mixvigorously. Solution viscosity is 1,500 centipoise.

Example BF Paste

A paste is prepared by adding 2 grams of a medium viscositycarboxymethyl cellulose (CMC 7MF from Hercules, Inc.) to a mixture of35.8 grams of cool water and 40 grams of glycerine with vigorous mixingfor 30 minutes. To this mixture is added 20 grams of fine tobaccopowder, 0.2 grams of sucralose, and 2 grams of cinnamon flavor. A thickpaste is prepared which is highly shear sensitive. This paste can beintroduced to a tube or other squeezable package where the shear forcefrom squeezing reduces the viscosity to permit flow of the paste.

Other Embodiments

The description of the specific embodiments of the invention ispresented for the purposes of illustration. It is not intended to beexhaustive nor to limit the scope of the invention to the specific formsdescribed herein. Although the invention has been described withreference to several embodiments, it will be understood by one ofordinary skill in the art that various modifications can be made withoutdeparting from the spirit and the scope of the invention, as set forthin the claims. All patents, patent applications, and publicationsreferenced herein are hereby incorporated by reference.

Other embodiments are within the claims.

What is claimed is:
 1. A smokeless tobacco product comprising: a unitaryporous insoluble matrix having interstices, the porous insoluble matrixincluding open cell polyurethane; and a tobacco composition coated onthe unitary porous insoluble matrix, the tobacco composition including,a non-combustible tobacco configured to be orally consumed and having anaverage particle size of less than or equal to about 250 μm, and aplasticizer, wherein the tobacco composition forms a coating thatsaturates the smokeless tobacco product and uniformly covers all of theinterstices of the unitary porous insoluble matrix, and the smokelesstobacco product has a maximum dimension ranging from about 5 mm to about15 mm.
 2. The product of claim 1, wherein the non-combustible tobaccohas an average particle size of less than or equal to about 80 μm. 3.The product of claim 1, wherein the non-combustible tobacco has anaverage particle size of less than or equal to about 50 μm.
 4. Theproduct of claim 1, wherein the non-combustible tobacco has an averageparticle size of less than or equal to about 25 μm.
 5. The product ofclaim 1, wherein the non-combustible tobacco has an average particlesize of less than or equal to about 20 μm or less.
 6. The product ofclaim 1, wherein the non-combustible tobacco is present in an amountranging from about 1% to about 80% on a dry weight basis.
 7. The productof claim 1, wherein the non-combustible tobacco is present in an amountranging from about 20% to about 50% tobacco on a dry weight basis. 8.The product of claim 1, wherein the tobacco composition further includesan extract of tobacco including two or more tobacco organolepticcomponents.
 9. The product of claim 1, wherein the tobacco compositionfurther includes a water soluble polymer.
 10. The product of claim 1,wherein the tobacco composition further includes a sweetener.
 11. Asmokeless tobacco product comprising: a unitary porous insoluble matrixhaving interstices, the unitary porous insoluble matrix including opencell polyurethane foam; and a tobacco composition coated on the unitaryporous insoluble matrix, the tobacco composition including, sodiumalginate, calcium salt, a plasticizer, and a non-combustible tobaccoconfigured to be orally consumed and having an average particle size ofless than or equal to about 250 μm, wherein the tobacco compositionforms a coating that saturates and uniformly covers all of theinterstices of the unitary porous insoluble matrix, and wherein thesmokeless tobacco product has a maximum dimension ranging from about 5mm to about 15 mm.
 12. The product of claim 11, wherein thenon-combustible tobacco has an average particle size of less than orequal to about 80 μm.
 13. A smokeless tobacco product comprising: aunitary porous insoluble matrix having interstices and including opencell polyurethane foam; and a tobacco composition including, anon-combustible tobacco in an amount ranging from about 1 weight percentto about 90 weight percent, a flavorant in an amount ranging from about1 weight percent to about 40 weight percent, fiber in an amount rangingfrom about 2 weight percent to about 40 weight percent, a sweetener inan amount ranging from about 0.2 weight percent to about 6 weightpercent, and a plasticizer in an amount ranging from about 1 weightpercent to about 40 weight percent, wherein the tobacco compositionforms a coating that saturates the smokeless tobacco product anduniformly covers all of the interstices of the unitary porous insolublematrix, and the smokeless tobacco product has a maximum dimensionranging from about 5 mm to about 15 mm.
 14. The product of claim 13,wherein the tobacco composition further includes a water soluble polymerin an amount ranging from about 10 weight percent to about 70 weightpercent.
 15. The product of claim 13, wherein the tobacco compositionfurther includes starch, maltodextrin, or both starch and maltodextrinin an amount ranging from about 1 weight percent to about 40 weightpercent.
 16. The product of claim 13, wherein the tobacco compositionfurther includes a lubricant in an amount ranging from about 0.5 weightpercent to about 10 weight percent.
 17. The product of claim 13, whereinthe non-combustible tobacco has an average particle size of less than orequal to about 250 μm.
 18. The product of claim 13, wherein thenon-combustible tobacco is an extract of tobacco.
 19. The product ofclaim 13, wherein the fiber includes insoluble fiber.
 20. The product ofclaim 13, wherein the fiber includes soluble fiber.
 21. The product ofclaim 13, wherein the tobacco composition includes, the non-combustibletobacco in an amount ranging from about 20 weight percent to about 40weight percent, the flavorant in an amount ranging from about 5 weightpercent to about 15 weight percent, the sweetener in an amount rangingfrom about 2 weight percent to about 5 weight percent, the fiber in anamount ranging from about 5 weight percent to about 20 weight percent,the fiber including insoluble fiber, and the plasticizer in an amountranging from about 5 weight percent to about 15 weight percentplasticizers.
 22. A smokeless tobacco product comprising: a unitaryporous insoluble matrix having interstices and including open cellpolyurethane foam; and a tobacco composition including, anon-combustible tobacco configured to be orally consumed in an amountranging from about 1 weight percent to about 90 weight percent, thenon-combustible tobacco having an average particle size of less than orequal to about 250 μm, a flavorant in an amount ranging from about 1weight percent to about 40 weight percent, fiber in an amount rangingfrom about 2 weight percent to about 40 weight percent, the fiberincluding soluble fiber, a sweetener in an amount ranging from about 0.2weight percent to about 6 weight percent, and a plasticizer in an amountranging from about 1 weight percent to about 40 weight percent, whereinthe tobacco composition forms a coating saturates the smokeless tobaccoproduct and uniformly covers all of the interstices of the unitaryporous insoluble matrix, and the smokeless tobacco product has a maximumdimension ranging from about 5 mm to about 15 mm.
 23. A smokelesstobacco product comprising: a unitary porous insoluble matrix includingopen cell polyurethane foam; and a tobacco composition coated on theunitary porous insoluble matrix, the tobacco composition consisting of,a non-combustible tobacco configured to be orally consumed, thenon-combustible tobacco having an average particle size of less than orequal to about 250 μm, and a plasticizer, wherein the smokeless tobaccoproduct has a maximum dimension ranging from about 5 mm to about 15 mm.24. The smokeless tobacco product of claim 1, wherein the tobaccoproduct is a convex or concave pellet.
 25. The smokeless tobacco productof claim 1, wherein the smokeless tobacco product has a rectangularcross section.
 26. The smokeless tobacco product of claim 1, wherein thesmokeless tobacco product has an oval cross section.
 27. The smokelesstobacco product of claim 1, wherein the smokeless tobacco product has anelliptical cross section.
 28. The smokeless tobacco product of claim 1,wherein a surface of the smokeless tobacco product defines a positive ornegative relief pattern.